AFFILIATIONSForaffiliationspleaseseeAcknowledgementssectionCORRESPONDENCEVBrusascoInternalMedicineUniversityofGenoaVleBenedettoXV6I16132GenovaFax39103537690EmailvitobrusascounigeitReceived ID: 955440
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SERIESATS/ERSTASKFORCE:STANDARDISATIONOFLUNGFUNCTIONTESTINGEditedbyV.Brusasco,R.CrapoandG.ViegiNumber2inthisSeriesStandardisationofspirometryM.R.Miller,J.Hankinson,V.Brusasco,F.Burgos,R.Casaburi,A.Coates,R.Crapo,P.Enright,C.P.M.vanderGrinten,P.Gustafsson,R.Jensen,D.C.Johnson,N.MacIntyre,R.McKay,D.Navajas,O.F.Pedersen,R.Pellegrino,G.ViegiandJ.Wanger...............................................................320andFVCmanoeuvre....................................................321Definitions...............................................................321 AFFILIATIONSForaffiliations,pleaseseeAcknowledgementssectionCORRESPONDENCEV.BrusascoInternalMedicineUniversityofGenoaV.leBenedettoXV,6I-16132GenovaFax:39103537690E-mail:vito.brusasco@unige.itReceived:March232005Acceptedafterrevision:April052005EuropeanRespiratoryJournalPrintISSN0903-1936OnlineISSN1399-3003 VCandIVC................................329IC.......................................329Equipment..................................329Testprocedure...............................329VC......................................329IC.......................................330Useofanoseclip...........................330Within-manoeuvreevaluation.....................330Between-manoeuvreevaluation...................330Testresultselection...........................330Peakexpiratoryflow...........................330Definition...................................330Equipment..................................330Testprocedure...............................330Within-manoeuvreevaluation.....................331Between-manoeuvreevaluation...................331Testresultselection...........................331Maximumvoluntaryventilation...................331Definition...................................331Equipment..................................331Testprocedure...............................331Within-manoeuvreevaluation.....................331Between-manoeuvreevaluation...................331Testresultselection...........................331Technicalconsiderations........................331Minimalrecommendationsforspirometrysystems......331BTPScorrection..............................332Comments................................332Testsignalsforspirometertesting.................333Method...................................333Accuracytest..............................333Repeatabilitytest............................333TestsignalsforPEFmetertesting.................333Method...................................333Accuracytest..............................333Repeatabilitytest............................334TestsignalsforMVVtesting......................334.................................334....................................335Peakexpiratoryflow,spirometry,spirometrystandardisation,spirometrytechnique,spirometrytraning,Spirometryisaphysiologicaltestthatmeasureshowanindividualinhalesorexhalesvolumesofairasafunctionoftime.Theprimarysignalmeasuredinspirometrymaybevolumeorflow.Spirometryisinvaluableasascreeningtestofgeneralrespiratoryhealthinthesamewaythatbloodpressureprovidesimportantinformationaboutgeneralcardiovascularhealth.However,onitsown,spirometrydoesnotleadcliniciansdirectlytoanaetiologicaldiagnosis.Someindica-tionsforspirometryaregivenintable1.Inthisdocument,themostimportantaspectsofspirometryaretheforcedvitalcapacity(FVC),whichisthevolumedeliveredduringanexpirationmadeasforcefullyandcompletelyaspossiblestartingfromfullinspiration,andtheforcedexpira-toryvolume(FEV)inonesecond,whichisthevolumedeliveredinthefirstsecondofanFVCmanoeuvre.OtherspirometricvariablesderivedfromtheFVCmanoeuvrearealsoaddressed.Spirometrycanbeundertakenwithmanydifferenttypesofequipment,andrequirescooperationbetweenthesubjectandtheexaminer,andtheresultsobtainedwilldependontechnicalaswellaspersonalfactors(fig.1).Ifthevariabilityoftheresultscanbediminishedandthemeasurementaccuracycanbeimproved,therangeofnormalvaluesforpopulationscanbenarrowedandabnormalitiesmoreeasil
ydetected.TheSnowbirdworkshopheldin1979resultedinthefirstAmericanThoracicSociety(ATS)statementonthestandardisationofspirometry[1].Thiswasupdatedin1987andagainin1994[2,3].AsimilarinitiativewasundertakenbytheEuropeanCommunityforSteelandCoal,resultinginthefirstEuropeanstandardisationdocumentin1983[4].Thiswasthenupdatedin1993astheofficialstatementoftheEuropeanRespiratorySociety(ERS)[5].TherearegenerallyonlyminordifferencesbetweenthetwomostrecentATSandERSstatements,exceptthattheERSstatementincludesabsolutelungvolumesandtheATSdoesnot.ThisdocumentbringstheviewsoftheATSandERStogetherinanattempttopublishstandardsthatcanbeappliedmore TABLE1IndicationsforspirometryToevaluatesymptoms,signsorabnormallaboratorytestsTomeasuretheeffectofdiseaseonpulmonaryfunctionToscreenindividualsatriskofhavingpulmonarydiseaseToassesspre-operativeriskToassessprognosisToassesshealthstatusbeforebeginningstrenuousphysicalactivityprogrammesToassesstherapeuticinterventionTodescribethecourseofdiseasesthataffectlungfunctionTomonitorpeopleexposedtoinjuriousagentsTomonitorforadversereactionstodrugswithknownpulmonarytoxicityDisability/impairmentevaluationsToassesspatientsaspartofarehabilitationprogrammeToassessrisksaspartofaninsuranceevaluationToassessindividualsforlegalreasonsPublichealthEpidemiologicalsurveysDerivationofreferenceequationsClinicalresearchSTANDARDISATIONOFSPIROMETRYM.R.MILLERETAL.VOLUME26NUMBER2EUROPEANRESPIRATORYJOURNAL widely.Thestatementisstructuredtocoverdefinitions,equipmentandpatient-relatedprocedures.Allrecordingdevicescoveredbythisstatementmustmeettherelevantrequirements,regardlessofwhethertheyareformonitoringordiagnosticpurposes.Thereisnoseparatecategoryformonitoringdevices.Althoughmanufacturershavetheresponsibilityforproducingpulmonaryfunctiontestingsystemsthatsatisfyalltherecommendationspresentedhere,itispossiblethat,forsomeequipment,meetingallofthemmaynotalwaysbeachievable.Inthesecircumstances,manufacturersshouldclearlyidentifywhichequipmentrequirementshavenotbeenmet.Whilemanufacturersareresponsiblefordemonstratingtheaccuracyandreliabilityofthesystemsthattheysell,itistheuserwhoisresponsibleforensuringthattheequipmentsmeasurementsremainaccurate.Theuserisalsoresponsibleforfollowinglocallaw,whichmayhaveadditionalrequirements.Finally,theseguidelinesareminimumguidelines,whichmaynotbesufficientforallsettings,suchaswhenconductingresearch,epidemiologicalstudies,longitudinalevaluationsandoccupa-tionalsurveillance.ANDFVCMANOEUVREFVCisthemaximalvolumeofairexhaledwithmaximallyforcedeffortfromamaximalinspiration,vitalcapacityperformedwithamaximallyforcedexpiratoryeffort,expressedinlitresatbodytemperatureandambientpressuresaturatedwithwatervapour(BTPS;seeBTPScorrectionisthemaximalvolumeofairexhaledinthefirstsecondofaforcedexpirationfromapositionoffullinspiration,expressedinlitresatBTPS.Thespirometermustbecapableofaccumulatingvolumefor15s(longertimesarerecommended)andmeasuringvolumesof8L(BTPS)withanaccuracyofatleast3%ofreadingor0.050L,whicheverisgreater,withflowsbetween0and14L.Thetotalresistancetoairflowat14.0L1.5cmH(0.15kPa;seeMinimalrecommen-dationsforspirometrysystemssection).Thetotalresistancemustbemeasuredwithanytubing,valves,pre-filter,.includedthatmaybeinsertedbetweenthesubjectandthespirometer.Somedevicesmayexhibitchangesinresistanceduetowatervapourcondensation,andaccuracyrequirementsmustbemetunderBTPSconditionsforuptoeightsuccessiveFVCmanoeuvresperformedina10-minperiodwithoutinspirationfromtheinstrument.Foroptimalqualitycontrol,bothflowvolumeandvolumetimedisplaysareuseful,andtestoperatorsshouldvisuallyinspecttheperformanceofeachmanoeuvreforqualityassurancebeforeproceedingwithanothermanoeuvre.Thisinspectionrequirestracingstomeettheminimumsizeandresolutionrequirementssetforthinthisstandard.Displaysofflowvolumeprovidemoredetailfortheinitialportion(first1s)oftheFVCmanoeuvre.Sincethisportionofthemanoeuvre,particularlythepeakexpiratoryflow(PEF),iscorrelatedwiththepleuralpressuredurin
gthemanoeuvre,theflowvolumedisplayisusefultoassessthemagnitudeofeffortduringtheinitialportionsofthemanoeuvre.Theabilitytooverlayaseriesofflowvolumecurvesregisteredatthepointofmaximalinhalationmaybehelpfulinevaluatingrepeatabilityanddetectingsub-maximalefforts.However,ifthepointofmaximalinhala-tionvariesbetweenblows,thentheinterpretationoftheseresultsisdifficultbecausetheflowsatidenticalmeasuredvolumesarebeingachievedatdifferentabsolutelungvolumes.Incontrast,displayoftheFVCmanoeuvreasavolumetimegraphprovidesmoredetailforthelatterpartofthemanoeuvre.AvolumetimetracingofsufficientsizealsoallowsindependentmeasurementandcalculationofparametersfromtheFVCmanoeuvres.Inadisplayofmultipletrials,thesequencingoftheblowsshouldbeapparenttotheuser.Forthestartoftestdisplay,thevolumetimedisplayshould0.25s,andpreferably1s,beforeexhalationstarts(zerovolume).Thistimeperiodbeforethereisanychangeinvolumeisneededtocalculatethebackextrapolatedvolume(EV;seeStartoftestcriteriasection)andtoevaluateeffortduringtheinitialportionofthemanoeuvre.Timezero,asdefinedbyEV,mustbepresentedasthezeropointonthegraphicaloutput.Thelast2softhemanoeuvreshouldbedisplayedtoindicateasatisfactoryendoftest(seeEndoftestcriteriaWhenavolumetimecurveisplottedashardcopy,thevolumescalemustbe10mm(BTPS).Forascreendisplay,5mmissatisfactory(table2).Thetimescaleshouldbe20mm,andlargertimescalesarepreferred(30mm)whenmanualmeasure-mentsaremade[1,6,7].Whenthevolumetimeplotisusedinconjunctionwithaflowvolumecurve(bothdisplaymethodsareprovidedforinterpretationsandnohand FIGURE1.Spirometrystandardisationsteps.M.R.MILLERETAL.STANDARDISATIONOFSPIROMETRYEUROPEANRESPIRATORYJOURNALVOLUME26NUMBER2 measurementsareperformed),thetimescalerequirementisreducedto10mmfromtheusuallyrequiredminimumof20mm(table2).TherationaleforthisexceptionisthattheflowvolumecurvecanprovidethemeansforqualityassessmentduringtheinitialportionoftheFVCmanoeuvre.ThevolumetimecurvecanbeusedtoevaluatethelatterpartoftheFVCmanoeuvre,makingthetimescalelesscritical.Itisstronglyrecommendedthatspirometrysystemsshouldbeevaluatedusingacomputer-drivenmechanicalsyringeoritsequivalent,inordertotesttherangeofexhalationsthatarelikelytobeencounteredinthetestpopulation.Testingtheperformanceofequipmentisnotpartoftheusuallaboratoryprocedures(seeTestsignalsforspirometertestingQualitycontrolAttentiontoequipmentqualitycontrolandcalibrationisanimportantpartofgoodlaboratorypractice.Ataminimum,therequirementsareasfollows:1)alogofcalibrationresultsismaintained;2)thedocumentationofrepairsorotheralterationswhichreturntheequipmenttoacceptableopera-tion;3)thedatesofcomputersoftwareandhardwareupdatesorchanges;and4)ifequipmentischangedorrelocated(industrialsurveys),calibrationchecksandquality-controlproceduresmustberepeatedbeforefurthertestingbegins.Keyaspectsofequipmentqualitycontrolaresummarisedintable3.Calibrationistheprocedureforestablishingtherelationshipbetweensensor-determinedvaluesoffloworvolumeandtheactualfloworvolume.Acalibrationcheckisdifferentfromcalibrationandistheprocedureusedtovalidatethatthedeviceiswithincalibration3%oftrue.Ifadevicefailsitscalibrationcheck,thenanewcalibrationprocedureorequipmentmaintenanceisrequired.Calibrationchecksmustbeundertakendaily,ormorefrequently,ifspecifiedbythemanufacturer.Thesyringeusedtocheckthevolumecalibrationofspiro-metersmusthaveanaccuracyof15mLor0.5%ofthefullscale(15mLfora3-Lsyringe),andthemanufacturermustproviderecommendationsconcerningappropriateintervalsbetweensyringecalibrationchecks.Usersshouldbeawarethatasyringewithanadjustableorvariablestopmaybeoutofcalibrationifthestopisresetoraccidentallymoved.Calibrationsyringesshouldbeperiodically(monthly)leaktestedatmorethanonevolumeuptotheirmaximum;thiscanbedonebyattemptingtoemptythemwiththeoutletcorked.Adroppedordamagedsyringeshouldbeconsideredoutofcalibrationuntilitischecked.Withregardtotime
,assessingmechanicalrecordertimescaleaccuracywithastopwatchmustbeperformedatleastquarterly.Anaccuracyofwithin2%mustbeachieved.Qualitycontrolforvolume-measuringdevicesThevolumeaccuracyofthespirometermustbecheckedatleastdaily,withasingledischargeofa3-Lcalibratedsyringe.Dailycalibrationcheckingishighlyrecommendedsothattheonsetofaproblemcanbedeterminedwithin1day,andalsotohelpdefineday-to-daylaboratoryvariability.Morefrequentchecksmayberequiredinspecialcircumstances,suchas:1)duringindustrialsurveysorotherstudiesinwhichalargenumberofsubjectmanoeuvresarecarriedout,theequipmentscalibrationshouldbecheckedmorefrequentlythandaily[8];and2)whentheambienttemperatureischanging(e.g.fieldstudies),volumeaccuracymustbecheckedmorefrequentlythandailyandtheBTPScorrectionfactorappropriatelyupdated.Theaccuracyofthesyringevolumemustbeconsideredindeterminingwhetherthemeasuredvolumeiswithinaccep-tablelimits.Forexample,ifthesyringehasanaccuracyof0.5%,areadingof3.5%isappropriate.Thecalibrationsyringeshouldbestoredandusedinsuchawayastomaintainthesametemperatureandhumidityofthetestingsite.Thisisbestaccomplishedbykeepingthesyringeincloseproximitytothespirometer,butoutofdirectsunlightandawayfromheatsources.Volume-typespirometersystemsmustbeevaluatedforleakseveryday[9,10].Theimportanceofundertakingthisdailytestcannotbeoverstressed.Leakscanbedetectedbyapplyingaconstantpositivepressureof3.0cmHO(0.3kPa)withthespirometeroutletoccluded(preferablyatorincludingthemouthpiece).Anyobservedvolumeloss30mLafter1minindicatesaleak[9,10]andneedstobecorrected. TABLE2Recommendedminimumscalefactorsfortime,volumeandflowongraphicaloutputInstrumentdisplayHardcopygraphicaloutputParameterResolutionResolution0.050L5mm0.025L10mm0.200L2.5mm0.100L5mmTime0.2s10mm0.2s20mm:thecorrectaspectratioforaflowvolumedisplayistwounitsofflowperoneunitofvolume. TABLE3SummaryofequipmentqualitycontrolTestMinimumintervalActionDailyCalibrationcheckwitha3-LsyringeDaily3cmHO(0.3kPa)constantpressurefor1minVolumelinearityQuarterly1-LincrementswithacalibratingsyringemeasuredoverentirevolumerangeFlowlinearityWeeklyTestatleastthreedifferentflowrangesQuarterlyMechanicalrecordercheckwithstopwatchNewversionsLoginstallationdateandperformtestusingknownsubjectSTANDARDISATIONOFSPIROMETRYM.R.MILLERETAL.VOLUME26NUMBER2EUROPEANRESPIRATORYJOURNAL Atleastquarterly,volumespirometersmusthavetheircalibrationcheckedovertheirentirevolumerangeusingacalibratedsyringe[11]oranequivalentvolumestandard.Themeasuredvolumeshouldbewithin3.5%ofthereadingor65mL,whicheverisgreater.Thislimitincludesthe0.5%accuracylimitfora3-Lsyringe.Thelinearitycheckprocedureprovidedbythemanufacturercanbeusedifitisequivalenttooneofthefollowingprocedures:1)consecutiveinjectionsof1-Lvolumeincrementswhilecomparingobservedvolumewiththecorrespondingcumulativemeasuredvolume,12,23, 67and78L,foran8-Lspirometer;and2)injectionofa3-Lvolumestartingataminimalspirometervolume,thenrepeatingthiswitha1-Lincrementinthestart03,14,25,36,47and58L,foran8-LThelinearitycheckisconsideredacceptableifthespirometermeetsthevolumeaccuracyrequirementsforallvolumesQualitycontrolforflow-measuringdevicesWithregardstovolumeaccuracy,calibrationchecksmustbeundertakenatleastdaily,usinga3-Lsyringedischargedatleastthreetimestogivearangeofflowsvaryingbetween0.5and12L(with3-Linjectiontimesof6sand0.5s).Thevolumeateachflowshouldmeettheaccuracyrequirementof3.5%.Fordevicesusingdisposableflowsensors,anewsensorfromthesupplyusedforpatienttestsshouldbetestedeachday.Forlinearity,avolumecalibrationcheckshouldbeper-formedweeklywitha3-Lsyringetodeliverthreerelativelyconstantflowsatalowflow,thenthreeatamid-rangeflowandfinallythreeatahighflow.ThevolumesachievedateachoftheseflowsshouldeachmeettheaccuracyrequirementofTestprocedureTherearethreedistinctphasestotheFVCmanoeuvre,asfollows:1)maximalinspiration;2)ablastofexhalation;and3)continuedcompleteexhalationtotheendoftest(EOT).Thetechnicianshoulddemonstratetheappropriatetechniqueandfollo
wtheproceduredescribedintable4.Thesubjectshouldinhalerapidlyandcompletelyfromfunctionalresidualcapacity(FRC),thebreathingtubeshouldbeinsertedintothesubjectsmouth(ifthishasnotalreadybeendone),makingsurethelipsaresealedaroundthemouthpieceandthatthetonguedoesnotoccludeit,andthentheFVCmanoeuvreshouldbebegunwithminimalhesitation.ReductionsinPEFandFEVhavebeenshownwheninspirationisslowand/orthereisa46spauseattotallungcapacity(TLC)beforebeginningexhalation[12].Itis,therefore,importantthattheprecedinginspirationisfastandanypauseatfullinspirationbeminimal(onlyfor12s).Thetestassumesafullinhalationbeforebeginningtheforcedexhalation,anditisimperativethatthesubjecttakesacompleteinhalationbeforebeginningthemanoeuvre.Thesubjectshouldbepromptedtoblast,notjustblow,theairfromtheirlungs,andthenhe/sheshouldbeencouragedtofullyexhale.Throughoutthemanoeuvre,enthusiasticcoachingofthesubjectusingappro-priatebodylanguageandphrases,suchaskeepgoing,isrequired.Itisparticularlyhelpfultoobservethesubjectwithoccasionalglancestocheckfordistress,andtoobservethetracingorcomputerdisplayduringthetesttohelpensuremaximaleffort.Ifthepatientfeelsdizzy,themanoeuvreshouldbestopped,sincesyncopecouldfollowduetoprolongedinterruptionofvenousreturntothethorax.Thisismorelikelytooccurinoldersubjectsandthosewithairflowlimitation.Performingavitalcapacity(VC)manoeuvre(seeandICmanoeuvresection),insteadofobtainingFVC,mayhelptoavoidsyncopeinsomesubjects.Reducingtheeffortpart-waythroughthemanoeuvre[13]maygiveahigherexpiratoryvolumeinsomesubjects,butthenisnolongeramaximallyforcedexpiration.Well-fittingfalseteethshouldnotberoutinelyremoved,sincetheypreserveoropharyngealgeome-tryandspirometryresultsaregenerallybetterwiththeminplace[14].Withappropriatecoaching,childrenasyoungas5yrsofageareoftenabletoperformacceptablespirometry[15].Thetechnicianswhoareinvolvedinthepulmonaryfunctiontestingofchildrenshouldbespecificallytrainedtodealwithsuchasituation.Abright,pleasantatmosphere, TABLE4ProceduresforrecordingforcedvitalcapacityCheckthespirometercalibrationExplainthetestPreparethesubjectAskaboutsmoking,recentillness,medicationuse,MeasureweightandheightwithoutshoesWashhandsInstructanddemonstratethetesttothesubject,toincludeCorrectposturewithheadslightlyelevatedInhalerapidlyandcompletelyPositionofthemouthpiece(opencircuit)ExhalewithmaximalforcePerformmanoeuvre(closedcircuitmethod)HavesubjectassumethecorrectpostureAttachnoseclip,placemouthpieceinmouthandcloselipsaroundtheInhalecompletelyandrapidlywithapauseof1satTLCExhalemaximallyuntilnomoreaircanbeexpelledwhilemaintaininganuprightRepeatinstructionsasnecessary,coachingvigorouslyRepeatforaminimumofthreemanoeuvres;nomorethaneightareusuallyChecktestrepeatabilityandperformmoremanoeuvresasnecessaryPerformmanoeuvre(opencircuitmethod)HavesubjectassumethecorrectpostureAttachnoseclipInhalecompletelyandrapidlywithapauseof1satTLCPlacemouthpieceinmouthandcloselipsaroundthemouthpieceExhalemaximallyuntilnomoreaircanbeexpelledwhilemaintaininganuprightRepeatinstructionsasnecessary,coachingvigorouslyRepeatforaminimumofthreemanoeuvres;nomorethaneightareusuallyChecktestrepeatabilityandperformmoremanoeuvresasnecessaryTLC:totallungcapacity.M.R.MILLERETAL.STANDARDISATIONOFSPIROMETRYEUROPEANRESPIRATORYJOURNALVOLUME26NUMBER2 includingage-appropriatetoys,readingmaterialandart,isimportantinmakingchildrenfeelatease.Encouragement,detailedbutsimpleinstructions,lackofintimidationandvisualfeedbackintheteachingareimportantinhelpingchildrentoperformthemanoeuvre.Evenifunsuccessfulatthefirstsession,childrenwilllearntobelessintimidatedandmayperformfarbetterinasubsequentsession.Testingchildreninadultlaboratories,wherenoeffortismadetocaterforthespecificneedsoftheyoungersubjects,istobediscouraged.Theuseofanoseclipormanualocclusionofthenaresisrecommended,and,forsafetyreasons,testingshouldbepreferablydoneinthesittingposition,usingachairwitharmsandwithoutwheels.Iftestingisundertakenwiththepatientstanding
orinanotherposition,thismustbedocumentedonthereport.Within-manoeuvreevaluationStartoftestcriteriaThestartoftest,forthepurposeoftiming,isdeterminedbythebackextrapolationmethod(fig.2)[1,3,9,16].Thenewtimezerofrombackextrapolationdefinesthestartforalltimedmeasurements.Formanualmeasurements,thebackextrapola-tionmethodtracesbackfromthesteepestslopeonthevolumetimecurve[17].Forcomputerisedbackextrapolation,itisrecommendedthatthelargestslopeaveragedoveran80-msperiodisused[18].Figure2providesanexampleandexplanationofbackextrapolationandthederivationofEV.ToachieveanaccuratetimezeroandassuretheFEVcomesfromamaximaleffortcurve,theEVmustbe5%oftheFVCor0.150L,whicheverisgreater.Ifamanoeuvrehasanobviouslyhesitantstart,thetechnicianmayterminatethetrialearlytoavoidanunnecessaryprolongedeffort.Rapidcomputerisedfeedbacktothetechnicianwhenthestartcriteriaarenotmetisstronglyencouraged.Inadditiontotheexpiratorymanoeuvre,thevolume-timecurvedisplay(graph)shouldideallyincludethewholeprecedinginspiratorymanoeuvre,butmustinclude0.25sandpreferablypriortothestartofexhalation(timezero).TheequipmentshoulddisplaytheEVvalue.Inspectionoftheflowvolumecurvemaybeaddedasameasureofthesatisfactorystartoftest.PEFshouldbeachievedwithasharpriseandoccurclosetothepointofmaximalinflation,thestartofexhalation(seeEndoftestcriteriaItisimportantforsubjectstobeverballyencouragedtocontinuetoexhaletheairattheendofthemanoeuvretoobtainoptimaleffort,bysayingkeepgoing.EOTcriteriaareusedtoidentifyareasonableFVCeffort,andtherearetworecommendedEOTcriteria,asfollows.1)Thesubjectcannotorshouldnotcontinuefurtherexhalation.Althoughsubjectsshouldbeencouragedtoachievetheirmaximaleffort,theyshouldbeallowedtoterminatethemanoeuvreontheirownatanytime,especiallyiftheyareexperiencingdiscomfort.Thetechnicianshouldalsobealerttoanyindicationthatthepatientisexperiencingdiscomfort,andshouldterminatethetestifapatientisbecominguncomfortableorisapproachingsyncope.2)Thevolumetimecurveshowsnochangeinvolume0.025L)for1s,andthesubjecthastriedtoexhalefor3sinchildrenaged10yrsandfor6sinsubjectsaged10yrs.Theequipmentshouldsignaltothetechnicianiftheplateaucriteriawerenotmet.AsatisfactoryEOTmaystillhavebeenachieved,butanequipmentalertwillhelpthetechniciantopinpointwherethesubjectmayneedmoreencouragement.Itisofnotethataclosureoftheglottismayprematurelyterminateamanoeuvreat6s,evenwhentheapparentdurationoftheblowexceeds6s.Forpatientswithairwaysobstructionoroldersubjects,exhalationtimesof6sarefrequentlyneeded.However,exhalationtimesof15swillrarelychangeclinicaldecisions.Multipleprolongedexhalationsareseldomjustifiedandmaycauselightheadedness,syncope,unduefatigueandunneces-sarydiscomfort.AchievingEOTcriteriaisonemeasureofmanoeuvreaccept-ability.ManoeuvresthatdonotmeetEOTcriteriashouldnotbeusedtosatisfytherequirementofthreeacceptablemanoeuvres.However,earlytermination,byitself,isnotareasontoeliminatealltheresultsfromsuchamanoeuvrefromfurtherconsideration.InformationsuchastheFEVmaybeuseful(dependingonthelengthofexhalation)andcanbereportedfromtheseearlyterminatedmanoeuvres.SomeyoungchildrenmayhavedifficultymeetingtheATSEOTcriteria[3],althoughtheymaymeetotherrepeatabilitycriteria[19].Curve-fittingtechniques[20]mayproveusefulindevelopingnewEOTcriteriaspecificforyoungchildren.AdditionalcriteriaAcoughduringthefirstsecondofthemanoeuvrecanaffectthemeasuredFEVvalue.Coughinginthefirstsecondoranyothercoughthat,inthetechniciansjudgment,interfereswiththemeasurementofaccurateresults[3]willrenderatest !"&!"'!"( $ ) . FIGURE2.Expandedversionoftheearlypartofasubjectsvolumetimespirogram,illustratingbackextrapolationthroughthesteepestpartofthecurve,whereflowispeakexpiratoryflow(PEF),todeterminethenewtimezero.Forcedvitalcapacity(FVC)4.291L;backextrapolatedvolume(EV)0.123L(2.9%FVC).-----:backextrapolationlinethroughPEF.STANDARDISATIONOFSPIROMETRYM.R.MILLERETAL.VOLUME26NUMBER2EUROPEANRESPIRATORYJOURNAL AValsalvamanoeuvre(glottisclosure)orhesitationduringth
emanoeuvrethatcausesacessationofairflowinamannerthatprecludesanaccurateestimateofeitherFEVorFVC[3]willrenderatestunacceptable.Theremustbenoleakatthemouth[3].Patientswithneuromusculardiseasemayrequiremanualorotherassistancefromthetechniciantoguaranteeanadequateseal.Obstructionofthemouthpiece,bythetonguebeingplacedinfrontofthemouthpieceorbyteethinfrontofthemouthpiece,orbydistortionfrombiting,mayaffecttheperformanceofeitherthedeviceorthesubject.SummaryofacceptableblowcriteriaTheacceptabilitycriteriaareasatisfactorystartoftestandasatisfactoryEOT,aplateauinthevolumetimecurve.Inaddition,thetechnicianshouldobservethatthesubjectunderstoodtheinstructionsandperformedthemanoeuvrewithamaximuminspiration,agoodstart,asmoothcontinuousexhalationandmaximaleffort.Thefollowingconditionsmustalsobemet:1)withoutanunsatisfactorystartofexpiration,characterisedbyexcessivehesitationorfalsestartextrapolatedvolumeorEV5%ofFVCor0.150L,whicheverisgreater(fig.2);2)withoutcoughingduringthefirstsecondofthemanoeuvre,therebyaffectingthemeasuredvalue,oranyothercoughthat,inthetechniciansjudgment,interfereswiththemeasurementofaccurateresults[3];3)withoutearlyterminationofexpiration(seeEndoftestsection);4)withoutaValsalvamanoeuvre(glottisclosure)orhesitationduringthemanoeuvrethatcausesacessationofairflow,whichprecludesaccuratemeasurementoforFVC[3];5)withoutaleak[3];6)withoutanobstructedmouthpiece(obstructionduetothetonguebeingplacedinfrontofthemouthpiece,orteethinfrontofthemouthpiece,ormouthpiecedeformationduetobiting);and7)withoutevidenceofanextrabreathbeingtakenduringthemanoeuvre.Itshouldbenotedthatausablecurvemustonlymeetconditions1and2above,whileanacceptablecurvemustmeetalloftheabovesevenconditions.Itisdesirabletouseacomputer-basedsystemthatprovidesfeedbacktothetechnicianwhentheaboveconditionsarenotmet.Thereportingformatshouldincludequalifiersindicatingtheacceptabilityofeachmanoeuvre.However,failuretomeetthesegoalsshouldnotnecessarilypreventreportingofresults,since,forsomesubjects,thisistheirbestperformance.Recordsofsuchmanoeuvresshouldberetainedsincetheymaycontainusefulinformation.Between-manoeuvreevaluationUsingthepreviouslydescribedcriteria,anadequatetestrequiresaminimumofthreeacceptableFVCmanoeuvres.AcceptablerepeatabilityisachievedwhenthedifferencebetweenthelargestandthenextlargestFVCis0.150LandthedifferencebetweenthelargestandnextlargestFEV0.150L[21].ForthosewithanFVCof1.0L,boththesevaluesare0.100L.Ifthesecriteriaarenotmetinthreemanoeuvres,additionaltrialsshouldbeattempted,upto,butusuallynomorethan,eightmanoeuvres.Largevariabilityamongtestsisoftenduetoincompleteinhalations.Somepatientsmayrequireabriefrestperiodbetweenmanoeuvres.VolumetimeorflowvolumecurvesfromatleastthebestthreeFVCmanoeuvresmustberetained.Table5givesasummaryofthewithin-andbetween-manoeuvreevaluation.ManoeuvrerepeatabilityForFVCmeasurements,acceptabilitymustbedeterminedbyascertainingthattherecommendationsoutlinedpreviouslyonperformingtheFVCtestaremet.TheguidelinesoftheATS[3]containexamplesofunacceptablevolumetimeandcorre-spondingflowvolumecurves.Figure3showsaflowchartoutlininghowthecriteriaforblowacceptabilityareappliedbeforethoseforrepeatability.TherepeatabilitycriteriaareusedtodeterminewhenmorethanthreeacceptableFVCmanoeuvresareneeded;thesecriteriaarenottobeusedtoexcluderesultsfromreportsortoexcludesubjectsfromastudy.Labellingresultsasbeingderivedfromdatathatdonotconformtotherepeatabilitycriteriadescribedpreviouslyisrecommended.Inaddition,therepeatabilitycriteriaareminimumrequirements.Manysub-jectsareabletoachieveFVCandFEVrepeatabilitytowithin0.150L.Manoeuvreswithanunacceptablestartoftestoracough(unusablecurve)mustbediscardedbeforeapplyingtherepeatabilitycriteriaandcannotbeusedindeterminingthebestvalues.ManoeuvreswithearlyterminationoraValsalvamanoeuvremaybeusedforselectingthelargestFVCand TABLE5Summaryofwithin-andbetween-manoeuvreacceptabilitycriteriaWithin-manoeuvrecriteriaIndividualspirogramsareacceptableifTheyare
freefromartefacts[3]CoughduringthefirstsecondofexhalationGlottisclosurethatinfluencesthemeasurementEarlyterminationorcut-offEffortthatisnotmaximalthroughoutObstructedmouthpieceTheyhavegoodstartsExtrapolatedvolume5%ofFVCor0.15L,whicheverisgreaterTheyshowsatisfactoryexhalationDurationof6s(3sforchildren)oraplateauinthevolumetimecurveorIfthesubjectcannotorshouldnotcontinuetoexhaleBetween-manoeuvrecriteriaAfterthreeacceptablespirogramshavebeenobtained,applythefollowingThetwolargestvaluesofFVCmustbewithin0.150LofeachotherThetwolargestvaluesofFEVmustbewithin0.150LofeachotherIfbothofthesecriteriaaremet,thetestsessionmaybeconcludedIfbothofthesecriteriaarenotmet,continuetestinguntilBothofthecriteriaaremetwithanalysisofadditionalacceptablespirogramsAtotalofeighttestshavebeenperformed(optional)orThepatient/subjectcannotorshouldnotcontinueSave,asaminimum,thethreesatisfactorymanoeuvresFVC:forcedvitalcapacity;FEV:forcedexpiratoryvolumeinonesecond.M.R.MILLERETAL.STANDARDISATIONOFSPIROMETRYEUROPEANRESPIRATORYJOURNALVOLUME26NUMBER2 Nospirogramortestresultshouldberejectedsolelyonthebasisofitspoorrepeatability.Therepeatabilityofresultsshouldbeconsideredatthetimeofinterpretation.TheuseofdatafrommanoeuvreswithpoorrepeatabilityorfailuretomeettheEOTrequirementsislefttothediscretionoftheMaximumnumberofmanoeuvresAlthoughtheremaybesomecircumstancesinwhichmorethaneightconsecutiveFVCmanoeuvresmaybeneeded,eightisgenerallyapracticalupperlimitformostsubjects[22,23].Afterseveralforcedexpiratorymanoeuvres,fatiguecanbegintotakeitstollonsubjectsandadditionalmanoeuvreswouldbeoflittleaddedvalue.Inextremelyrarecircumstances,subjectsmayshowaprogressivereductioninFEVorFVCwitheachsubsequentblow.Ifthecumulativedropexceeds20%ofstartvalue,thetestprocedureshouldbeterminatedintheinterestofpatientsafety.ThesequenceofthemanoeuvresshouldbeTestresultselectionFVCandFEVshouldbemeasuredfromaseriesofatleastthreeforcedexpiratorycurvesthathaveanacceptablestartoftestandarefreefromartefact,suchasacough(curves).ThelargestFVCandthelargestFEV(BTPS)shouldberecordedafterexaminingthedatafromalloftheusablecurves,eveniftheydonotcomefromthesamecurve.Otherderivedindicesisthemaximalvolumeexhaledbytimetseconds(timedfromthetimezerodefinedbybackextrapolation)ofaforcedexpirationfromapositionoffullinspiration,expressedinlitresatBTPS.Veryyoungchildrenmaynotbeabletoproduceprolongedexpirations,butthereisincreasingevidencethatindicesderivedfromblowswithforcedexpiratorytimesof1smayhaveclinicalusefulness[19].Atpresent,thereareinsufficientdatatorecommendtheuseofFEVorFEVWhenthesubjectdoesnotexhalecompletely,thevolumeaccumulatedoverashorterperiodoftime(6s)maybeusedasanapproximatesurrogateforFVC.Whensuchsurrogatesareused,thevolumelabelshouldreflecttheshorterexhalationtime(fora6-sexhalation).FEVhasbeenincreasinglyconsideredareasonablyreliablesurrogateforFVC[24]andcanbeusedfornormalisingFEV).RecordingFEVseemstohavetheadvantageofbeingmorereproduciblethanFVC,beinglessphysicallydemandingforpatientsandprovidingamoreexplicitEOT.Confirmationfromotherstudiesisrequired.StandardisationofFEVforexpiredvolume,FEV/FVCandFEVInsomepatients,asloworunforcedVCorinspiratoryvitalcapacity(IVC)manoeuvre(seeVCandICmanoeuvremayprovidealargerandmoreappropriatedenominatorforcalculationoftheFEV/VC%.SomeinvestigatorshavereportedthattheVCisslightlyhigherthantheFVCinnormalsubjects[25].Themeanforcedexpiratoryflowbetween25%and75%oftheFVC(FEF)hasalsobeenknownasthemaximummid-expiratoryflow.ThisindexistakenfromtheblowwiththelargestsumofFEVandFVC.TheFEFbemeasuredwithanaccuracyofatleast5%ofreadingor0.200Lwhicheverisgreater,overarangeofupto7LItshouldbenotedthatitishighlydependentonthevalidityoftheFVCmeasurementandthelevelofexpiratoryeffort.PEFisusuallyobtainedfromflowvolumecurvedata.Itisthemaximumexpiratoryflowachievedfromamaximumforcedexpiration,startingwithouthesitationfromthepointofmaximallunginflation,expressedinL.WhenPEFisrecordedusingapatient-administeredportablePEFmeter,itisof
tenexpressedinL.PEFiscoveredinmoredetaillater.MaximalexpiratoryflowvolumeloopsTheshapeofamaximumflowvolumeloop(MFVL),whichincludesforcedinspiratorymanoeuvres,canbehelpfulinqualitycontrolandindetectingthepresenceofupperairwayobstruction.NoneofthenumericalindicesfromaMFVLhasclinicalutilitysuperiortoFEV,FVC,FEFandPEF,andarenotconsideredindetailhere.Withregardtoinstantaneousflows,therecommendedmeasureistheinstantaneousforcedexpiratoryflowwhenX%oftheFVChasbeenexpired(FEF).ThemaximalinstantaneousforcedexpiratoryflowwhenX%oftheFVCremainstobeexpired(MEF)wasthetermpreviouslyrecommendedinEurope.InstantaneousforcedinspiratoryflowwhenX%oftheFVChasbeenexpired(FIF)andmid-inspiratoryflowwhenX%oftheFVChasbeenexpiredrefertotheflowsmeasuredontheinspiratorylimbofaflowvolumeloop.FIF,also , 0 1 1 , 1 555 FIGURE3.Flowchartoutlininghowacceptabilityandreapeatabilitycriteriaaretobeapplied.FVC:forcedvitalcapacity;FEV:forcedexpiratoryvolumeinoneSTANDARDISATIONOFSPIROMETRYM.R.MILLERETAL.VOLUME26NUMBER2EUROPEANRESPIRATORYJOURNAL referredtoasmaximalmid-inspiratoryflow,isanalogoustoOtherderivedindicesInstantaneousflowsmustbemeasuredwithanaccuracyof5%ofreadingor0.200L,whicheverisgreater,overarangeof-1414L.Thelevelofminimumdetectableflowshouldbe0.025L.Whenamaximumflowvolumeloopisplottedordisplayed,exhaledflowmustbeplottedupwards,andexhaledvolumetowardstheright.A2:1ratiomustbemaintainedbetweentheflowandvolumescales,flowand1Lofexhaledvolumemustbethesamedistanceontheirrespectiveaxes.Theflowandvolumescales,usedinreviewingtestperformance,mustbeequivalenttothatshownintable2.TestprocedureThesubjecthastomakeafullexpiratoryandinspiratoryloopasasinglemanoeuvre.Inmanylaboratories,thisistheprimarymanoeuvreforspirometry.ThesubjectisaskedtotakearapidfullinspirationtoTLCfromroomairthroughthemouth,theninsertthemouthpieceand,withouthesitation,performanexpirationwithmaximumforceuntilnomoregascanbeexpelled,followedbyaquickmaximuminspiration.Atthispoint,themanoeuvreisfinished.AnalternativeprocedureisforthesubjecttoinsertthemouthpiecewhileundertakingtidalbreathingatFRC,andthen,inonecontinuoussequence,dothefollowing:makeaslowexpirationtoresidualvolume(RV);followeddirectlybyaslowinspirationtoTLC;followthisbyarapidfullexpirationwithmaximalefforttoRV;andfollowedbyarapidfullinspirationwithmaximaleffortbacktoTLC.Thisprocedureisslightlymorecomplicatedandmaynotbesuitableforallequipment,butitobtainsameasurementofVCaswellasFVC.Within-andbetween-manoeuvreevaluationTheseevaluationsarethesameasforFVC(seemanoeuvreevaluationBetween-manoeuvreevaluationtions).Occasionally,asubjectisunabletoperformasatisfactoryinspiratorylimbimmediatelyfollowingamaximalforcedexpiratorymanoeuvre.Thisisparticularlycommonintheelderlyandtheinfirm.Inthesecircumstances,itmaybenecessaryforthesubjecttorecordaninspiratorymanoeuvreseparatelyfromtheexpiratorymanoeuvre.Equipmentshouldbeabletoperformtheseseparatelyandthenpresentthreeormoreloopstogetheronagraphicaldisplayoroutput.FlowvolumeloopexamplesThefollowingfigures(figures410)givetypicalexamplesofcommonlyencounteredflowvolumeloopconfigurations.TheadvantagesofvisualpatternrecognitionfromtheMFVLcanreadilybeappreciated.Theshapesofthemanoeuvresmustberepeatable(fig.10)foranyinterpretationtobemade.Thisisespeciallytruefortheplateaueffectonexpiratoryandinspiratorylimbsofthemanoeuvrefoundinupperairwayobstruction,asthiscanbemimickedbypooreffort,whichisusuallyvariablefromblowtoblow.AfurtherexplanationisgivenintheATS/ERSstatementonlungfunctioninterpreta-tion[26].ReversibilitytestingAdeterminationofairflow-limitationreversibilitywithdrugadministrationiscommonlyundertakenaspartoflungfunctiontesting.Thechoiceofdrug,doseandmodeofdeliveryisaclinicaldecisiondependingonwhattheclinicianwishestolearnfromthetest.Iftheaimofthetestistodeterminewhetherthepatientslungfunctioncanbeimprovedwi
ththerapyinadditiontotheirregulartreatment,thenthesubjectcancontinuewithhis/herregularmedicationpriortothetest.Iftheclinicianwantstodeterminewhetherthereisanyevidenceofreversibleairflowlimitation,thenthesubjectshouldundergobaselinefunctiontestingwhennottakinganydrugspriortothetest.Short-actinginhaleddrugs(agonistalbuterol/salbutamolortheanticholinergicagentipratropiumbromide)shouldnotbeusedwithin4hoftesting.-agonistbronchodilators(salmeterolorformoterol)andoraltherapywithaminophyllineorslow--agonistsshouldbestoppedfor12hpriortothetest.Smokingshouldbeavoidedfor1hpriortotestingandthroughoutthedurationofthetestprocedure.Thefollowingstepsareundertaken.1)ThesubjecthasthreeacceptabletestsofFEV,FVCandPEFrecordedasdescribedpreviously.2)Thedrugisadministeredinthedoseandbythemethodindicatedforthetest.Forexample,afteragentleandincompleteexpiration,adoseof100gofalbuterol/salbuta-molisinhaledinonebreathtoTLCfromavalvedspacerdevice.Thebreathisthenheldfor510sbeforethesubjectexhales.Fourseparatedoses(totaldose400g)aredeliveredat30-sintervals.Thisdoseensuresthattheresponseishighonthealbuteroldoseresponsecurve.Alowerdosecanbeusedifthereisconcernaboutanyeffectonthepatientsheartrateortremor.Otherdrugscanalsobeused.Fortheanticholinergicagentipratropiumbromide,thetotaldoseis160g(4Threeadditionalacceptabletestsarerecorded10minandupto15minlaterforshort-acting-agonists,and30minlaterforshort-actinganticholinergicagents.%(7'*&$ ) FIGURE4.Flowvolumeloopofanormalsubject.M.R.MILLERETAL.STANDARDISATIONOFSPIROMETRYEUROPEANRESPIRATORYJOURNALVOLUME26NUMBER2 CommentondoseanddeliverymethodStandardisingthebronchodilatordoseadministeredisnecessaryinordertostandardisethedefinitionofasignificantbronchodilatorresponse.Therateofpulmonarydepositionofadrugwithtidalbreathingfromanunventednebuliserwilldependondrugconcentration,rateofnebuliseroutput,particle-sizedistribution,andtheratioofthetimespentininspirationoverthetotalrespiratorytime(tot)[27].Thefractionoftheaerosolcarriedinparticleswithadiameterofmthatisexpectedtodepositinadultlungsifinhaledthroughamouthpiece[28]isdefinedastherespirablefraction(RF).Forexample,2.5mgofsalbutamol(albuterol)in2.5mLofsolution,placedinaHudsonUpdraftII(HudsonRCI,Temecula,CA,USA)drivenbyaPulmoAidecompressor(DeVilbiss,Somerset,PA,USA),wouldproduce0.1mgintheRF.Forarespiratoryrateof15breathsminandatotof0.45,thiswouldgivegdepositedinthelungsperbreath,or45min.Foradultsusingametereddoseinhaler(MDI)withavalve-holdingchamber(spacer),between10and20%[29,30]ofa100-gpuff(orgperactivation)wouldbeexpectedtobedepositedinthelungofanadult.Withoutaspacer,thedepositionwillbeless,andheavilytechniquedependent[31].Pulmonarydepositionfromdry-powderinhalersisdevicespecific,andbreath-enhancednebulisersdepositmuchmorethanunventedones[32,33].CFC-freeMDIsproduceasmallerparticle-sizedistributionandimproved(upto50%ofdose)lungdepositioncomparedwiththosewithCFCpropellant[34].Forchildren,pulmonarydepositionislessthanthatinadults[35],possiblyrelatingtothesizeoftheupperairway.Eachlaboratoryshouldbefamiliarwiththepulmonary-depositioncharacteristicsofthedevicestheyuse.DeterminationofreversibilityThisaspectiscoveredindetailintheinterpretativestrategydocumentoftheATSandERS[26]. %(7'*&$ ) FIGURE5.Flowvolumeloopofanormalsub-jectwithendexpiratorycurvilinearity,whichcanbeseenwithageing. %(7'*&$ ) FIGURE6.Moderateairflowlimitationinasubjectwithasthma. %(7'*&$ ) FIGURE7.Severeairflowlimitationinasubjectwithchronicobstructivepulmonarydisease. %(7'*&$ ) FIGURE8.Variableintra-thoracicupperairwayobstruction. %(7'*&$ ) FIGURE9.Variableextra-thoracicupperairwayobstruction. %(7'*&$ ) FIGURE10.Fixedupperairwayobstructionshownbythreemanoeuvres.STANDARDISATIONOFSPIROMETRYM.R.MILLERETAL.VOLUME26NUMBER2EUROPEANRESPIRATORYJOURNAL VCANDICMANOEUVREVCandIVCTheVCisthevolumechangeatthemouthbetweenthepositionoffullinspirationandcompleteexpiration,expressedinlitresatBTPS.TheslowVCcanbederivedintwowa
ys.Theexpiratoryvitalcapacity(EVC)isthemaximalvolumeofairexhaledfromthepointofmaximalinhalation.TheIVCisthemaximalvolumeofairinhaledfromthepointofmaximalexhalation,achievedbyaslowexpirationfromend-tidalinspiration.Thesemanoeuvresareunforced,exceptatthepointofreachingRVorTLC,respectively,whereextraeffortisrequired[36].Inspiratorycapacity(IC)isvolumechangerecordedatthemouthwhentakingaslowfullinspirationwithnohesitation,fromapositionofpassiveend-tidalexpiration,FRC,toapositionofmaximuminspiration,expressedinlitresatBTPS.ICisanindirectestimateofthedegreeoflunghyperinflationatrest,andisusefultoassesschangesinFRCwithpharmaco-logicalinterventionsandphysicalexercise[3741].FormeasurementsofVCandIC,thespirometerorflowmetermustcomplywiththerequirementsforFVC(asdescribedpreviously)andbecapableofaccumulatingvolumefor30s.Expiratorymanoeuvresor,ideally,bothinspiratoryandexpiratorymanoeuvresshouldbeincludedinthedisplayofVCmanoeuvre.Regardlessofwhethertheinspiratoryorexpiratorymanoeuvreisusedforderivingmeasurements,adisplayoftheentirerecordedVCmanoeuvremustbeprovided.Themaximalexpiratoryvolumemustbeassessedtodeterminewhetherthesubjecthasobtainedaplateauintheexpiratoryeffort.FordisplayoftheslowVC,thetimescalemaybereducedto5mmTestprocedureVCcanbemeasuredusingconventionalspirometers.Itmayalsoberecordedfromequipmentusedtomeasurestaticlungvolumesandtheirsubdivisions[42].ForslowVC,amaximumoffourmanoeuvresisapracticalupperlimit.ItispreferablethatVCmanoeuvresbeperformedbeforeFVCmanoeuvresbecauseofthepotentialformuscularfatigueandvolumehistoryeffects,where,aftermaximalinspiratoryefforts,somepatientswithsevereairwaysobstructionreturntoafalselyhighlevelofFRCorRV,duetogastrappingorstressrelaxation[3].TheVCmanoeuvremaybeconsideredeitherasanIVC,wherethesubjectinhalescompletelyfromapositionoffullexpiration,orasanEVC,wherethesubjectexhalescompletelyfromapositionoffullinspiration.Figure11showstherecordingofIVCandfigure12showsanEVCrecording.Importantdifferencesbetweeninspiratory(IVC)andexpiratory(EVC)manoeuvresmaybeobservedinpatientswithairwaysobstruction[43,44].ThetestisbegunbyinstructingthesubjectintheVCmanoeuvreanddemonstratingtheappropriatetechnique.Itisimportantthatsubjectsunderstandtheymustcompletelyfillandemptytheirlungs.TheVCmanoeuvreisperformedwiththesubjectusingamouthpieceandwearinganoseclip.Themanoeuvreisnotforced;itisperformedinarelaxedmanner,exceptnearend-inspirationandend-expiration.ThesubjectexhalescompletelytoRV,theninhalestoTLC,andfinallyexhalestoRVagain.Thetechnicianshouldencouragethesubjecttoreachmaximalinhaledandexhaledvolumeswitharelativelyconstantflow.Theexhalationshouldnotbeundulyslow,asthiscanleadtounderestimationofVC.Techniciansshouldobservethesubjectcarefullytoensurethathis/herlipsaresealed,nothingobstructsthemouthpiece,noleaksoccur,andthatTLCandRVarereached.Alternatively,thesubjectinhalesmaximally,insertsthemouthpiecejustpasthis/herfrontteeth,sealshis/herlipsaroundthemouthpiece,andblowsslowlyandevenlyuntilthereisnovolumechange(0.025L)fora1-speriod(seeoftestcriteriasection).Patientswithneuromusculardiseasemayneedassistanceinmaintainingatightsealatthemouth.Thetechnicianmustobservethesubjectsinhalationtoensure $. 3. FIGURE11.Tracingoftidalbreathingfollowedbyanexpiratorymanoeuvretoresidualvolume(RV),followedbyafullinspirationtototallungcapacity(TLC)torecordinspiratoryvitalcapacity(IVC)andinspiratorycapacity(IC).FRC:functionalresidualcapacity;ERV:expiratoryreservevolume. . 3FIGURE12.Tracingoftidalbreathingfollowedbyaninspiratorymanoeuvretototallungcapacity(TLC)torecordinspiratorycapacity(IC),followedbyafullexpirationtoresidualvolume(RV)torecordexpiratoryreservevolume(EVC).FRC:functionalresidualcapacity.M.R.MILLERETAL.STANDARDISATIONOFSPIROMETRYEUROPEANRESPIRATORYJOURNALVOLUME26NUMBER2 thatitiscomplete,andthatairisnotexhaledwhilethemouthpieceisbeinginserted.Thetechnicianshouldassurethattheexpiratorymanoeuvreisnotforced.Inhealthysubjects,adequatemax
imalinspiratoryandexpiratorylevelsareachievedwithin56s.Subjectsshouldbetestedintheseatedpositionwearinganoseclipwithnoairleaksbetweenthemouthandthemouthpiece.Subjectsshouldberelaxed(shouldersdownandrelaxed)andaskedtobreatheregularlyforseveralbreathsuntiltheend-expiratorylungvolumeisstable(thisusuallyrequiresatleastthreetidalmanoeuvres).TheyarethenurgedtotakeadeepbreathtoTLCwithnohesitation.Figure12showsatracingfromtherecordingofIC.UseofanoseclipTheuseofanoseclipisencouragedinVCmeasurements,sincesomepeoplebreathethroughthenosewhenperformingaslowVCmanoeuvre.AnoseclipmustbeusedwhenperforminginspiratorymanoeuvressuchastheIVCorIC.Within-manoeuvreevaluationThesearethesameasforFVCEOTcriteriaasdescribedpreviously.Theremustbenoleakatthemouth,nohesitationduringthemanoeuvre,andnoobstructionofthemouthpieceAdditionalcriteriasection).TheICmaybeunderestimatediftheinspiratorymanoeuvreistooslowduetopooreffortorhesitation,orifthereisprematureclosureoftheglottis.Between-manoeuvreevaluationAswithspirometry,aminimumofthreeacceptableVCmanoeuvresmustbeobtained.IfthedifferenceinVCbetweenthelargestandnextlargestmanoeuvreis0.150L,additionaltrialsshouldbeundertaken.Meetingrepeatabilitycriteriamayrequirethatupto,butusuallynomorethan,fourmanoeuvresareperformed,witharestperiodof1minbetweenthemanoeuvres.Largevariabilityinthistestisoftenduetoincompleteinhalations.VolumetimecurvesfromthebesttwoVCmanoeuvresmustberetained.FortheIC,atleastthreeacceptablemanoeuvresshouldbeperformed.ThemeancoefficientofvariationforICinchronicairflowobstructionhasbeenfoundtobe53%[39].TestresultselectionForVC,thelargestvaluefromatleastthreeacceptablemanoeuvresshouldbereported.ForIC,theaverageofatleastthreemanoeuvresshouldbereported.PEAKEXPIRATORYFLOWStudiesonthemeasurementofPEFareongoing.Recentevidencehassuggestedthatthepreviouslyappliedstandardsmayallowincorrectmeasurementstobemade[45],anditispossiblethatmorestringentrequirementsmayberequired.Afurtherstatementwillbemadewhenthepositionontheclinicalsignificanceofthisisclear.However,sincePEFmeasurementsarepartofasthma-managementprogrammes,thepreviousrecommendations[3,46]arereiteratedhere.Otherinstantaneousflowmeasurements(,FEFarenotproventobesuperiortoconventionalspirometricindicesinaclinicalsetting,and,therefore,arenotconsideredPEFisthehighestflowachievedfromamaximumforcedexpiratorymanoeuvrestartedwithouthesitationfromaposi-tionofmaximallunginflation[46].Whenitisobtainedfromflowvolumecurvedata,itisexpressedatBTPSinL.Thedefiningcharacteristicsoftheflowtimecurve,inrelationtoPEF,arethetimetakenforflowtorisefrom10%ofPEFto90%ofPEF,therisetime(RT),andthedurationthatflowisofPEF,calledthedwelltime(DT).WhenPEFisobtainedwithportablemonitoringinstruments,itisexpressedinLminIdeally,PEFshouldberecordedbyaninstrumentthatprimarilyrecordsflow.MeasuringPEFrequiresaninstrumentthathasaflatfrequencyresponse(5%)upto15Hz[46].AlthoughthereisevidenceofsignificantfrequencycontentinPEFupto20Hz[47],itisrecommended,atthisstage,thatmanufacturersachieveagoalofrecordingfidelityupto15Hz.ThePEFmustbemeasuredwithanaccuracyof0.3L(20L),whicheveristhegreater.Meaninstrumentresistancemeasuredacrosstherangeoftheinstrumentshouldbe2.5cmH(0.25kPatable6).PEFissensitivetotheresistanceofthemeter;forexample,aresistanceof0.25kPadecreasesPEFbycomparedwithPEFmeasuredwithalow-resistancepneumo-tachograph[48].Intra-instrumentrepeatabilitymustbe5%or0.150L(10L),whicheveristhegreater.Inter-devicereproduci-bilitymustbe10%or0.300L(20L),whicheveristhegreater.CalculatingPEFbydifferentiatingvolumetimedatamayintroducenoise;hence,aparabolic-fittingalgorithmmaybeused[2]asasmoothingprocedure.EquipmentvalidationiscoveredintheTestsignalsforPEFmetertestingTestprocedurePEFisdependentoneffortandlungvolume,withsubjectcooperationbeingessential.PEFmustbeachievedasrapidlyaspossibleandatashighalungvolumeaspossible,inordertoobtainthemaximumvalue[49].Thesubjectmustbeencouragedtoblowasvigorouslyaspossible.Theneckshouldbeinaneutralposition,notf
lexedorextended,andthesubjectmustnotcough.Anoseclipisnotnecessary.Afterthepointoffulllunginflation,thesubjectmustdelivertheblowwithoutanydelay.Hesitatingforaslittleas2sorflexingtheneckallowsthetrachealvisco-elasticpropertiestorelaxandPEFtodropbyasmuchas10%[50].Tonguing,spittingorcoughingatthestartoftheblowmayfalselyraisetherecordedPEFinsomedevices.Inthelaboratory,thesubjectmustperformaminimumofthreePEFmanoeuvres.WhenPEFisaself-administeredrecording,itisimportantthatthesubjecthasbeenadequatelytaughthowtoperformthetest,whentoperformitandwhatactiontotakedependingontheresultingvalueobtained.RegularchecksofthepatientsPEFtechniqueandmeterareanimportantpartofthefollow-up.STANDARDISATIONOFSPIROMETRYM.R.MILLERETAL.VOLUME26NUMBER2EUROPEANRESPIRATORYJOURNAL Within-manoeuvreevaluationThesubjectmustbeobservedtoensureagoodsealatthemouth,nohesitationoccurred,andtherewasnoabnormalstarttothemanoeuvre.Between-manoeuvreevaluationThePEFvaluesandtheirordermustberecordedsothatmanoeuvre-inducedbronchospasmcanbedetected.Ifthelargesttwooutofthreeacceptableblowsarenotreproduciblewithin0.67L(40L),uptotwoadditionalblowscanbeperformed.Ninety-fivepercentofuntrainedhealthysubjectsandpatientscanreproducePEFtowithin0.67L(40L),and90%towithin0.5L(30L)[48].Ifsatisfactoryrepeatabilityhasnotbeeninachievedinfiveattempts,morearenotlikelytobehelpful[51].TestresultselectionThelargestvaluefromatleastthreeacceptableblowsisMAXIMUMVOLUNTARYVENTILATIONThistesthasbeenlargelysupersededbyFEV,whichwasdefinedastheindexfromasinglemaximumforcedexpiratorymanoeuvrethatbestcorrelatedwithmaximumvoluntaryventilation(MVV).IfFEVisavailable,thenMVVhaslittleadditionalcontributiontomakeinaclinicalsetting.However,itmaybeusefulinthoseconditionswhereventilatorycapacitymaybeimpairedbymechanismsthataredifferentfromthoseaffectingFEVFEVDefinitionTheMVVisthemaximumvolumeofairasubjectcanbreatheoveraspecifiedperiodoftime(12sfornormalsubjects).ItisexpressedinLatBTPS.AspirometerusedformeasuringMVVmusthaveanamplitudefrequencyresponsethatisflat(10%)fromzero4Hz,atflowsofupto12L,overthevolumerange.Thetimeforexhaledvolumeintegrationorrecordingmustbenolessthan12sandnomorethan15s[52].Theindicatedtimemustbeaccuratetowithin3%.TheMVVmustbemeasuredwithanaccuracyof10%ofreadingor15Lwhicheverisgreater.TheevaluationofequipmentiscoveredintheTestsignalsforMVVtestingTestprocedureThetechnicianshouldprovideproperinstructionsanddemonstratethemanoeuvrepriortothestartoftesting.Thesubjectshouldbetestedinthesittingpositionwearinganoseclip.Afterthesubjectmakesanairtightsealaroundthemouthpiece,atleastthreerestingtidalbreathsshouldbeobtained,followedbybreathingasrapidlyanddeeplyaspossible.Thetongueandteethmustbepositionedsoastonotobstructairflow.Thetechnicianshouldenthusiasticallycoachthesubjectthroughoutthemanoeuvre,andmayneedtosuggestfasterorslowerbreathingtoachieveanidealrateof90110breathsmin[53,54],althoughsubjectswithdiseasemaynotalwaysachievethisrate.Thetechnicianwillneedtocarefullyobservethesubjectwithoccasionalglancesatthetracingtohelpthesubjecttoobtainanacceptablemanoeuvre.Anacceptablemanoeuvreshouldbeperformedwithmaximaleffortwithoutevidenceofleakage,hesitationormeasurementartefact.Thesubjectisinstructedtobreatheasdeeplyandrapidlyaspossibleandthetidalvolume()duringthemanoeuvreshouldbegreaterthanthesubjectsrestingThetestinterval(12s)shouldbereported.Arestbetweenmanoeuvreswillimprovesubsequentefforts.TheMVVshouldbecalculatedfromthesumofallindividualexhalations,multipliedbytheappropriateBTPScorrectionfactorduringthebest12softhemanoeuvre.Fromatechnicalstandpoint,changesinrespiratoryrateorduringthemanoeuvrewillinfluencetestresults.Within-manoeuvreevaluationInnormalsubjects,thegoalforanacceptableMVVshouldbeathatis50%oftheVC,withabreathingfrequencythatis90breaths[54].Itisunlikelythatanacceptablemanoeuvrewillbeobtainedwhenthebreathingfrequencyis65breaths[54].However,sincetherearelittledataonMVVacceptabilitycriteria,nospecificbreathingfrequencyorvolumeisrequired
.Theemphasisshouldbeonmaximaleffortwithagoalof90breathsandavolumerepresenting50%oftheVC.duringthemanoeuvreisprobablynotasimportantasbreathingfrequency,sincepatientstendtobreatheontheportionoftheexpiratorycurvewhereairisbestmovedatagivenfrequency.Between-manoeuvreevaluationThesubjectshouldperformaminimumoftwoacceptablemanoeuvres.Therearenoclinicalstudiesaddressingrepeat-ability;however,additionaltrialsshouldbeconsideredwhenthevariabilitybetweenacceptablemanoeuvresexceeds20%.TestresultselectionThehighestacceptableMVV(LBTPS)andMVVrate)shouldbereported.AnMVV/(400.80indicatesthattheMVVislowrelativetotheFEVandsuggestsdiseaseorpooreffort.Volumetracingsfromatleasttwoacceptablemanoeuvresshouldberetainedandavailableforinspection.TECHNICALCONSIDERATIONSMinimalrecommendationsforspirometrysystemsAccurateresultsrequireaccurateequipment.Spirometerequip-mentrecommendationsapplytoallspirometersandareminimalrequirements.Insomecircumstances,itmaybeappropriatetoexceedtheserequirements(i.e.insomeresearch/surveillanceapplications).Instrumentationrecommendationsshouldbefollowedtoprovideaccuratespirometricdataandinformationthatiscomparablefromlaboratorytolaboratoryandfromonetimeperiodtoanother[1].Theaccuracyofaspirometrysystemdependsoncharacteristicsoftheentiresystem,fromthevolumeorflowtransducerandtheuseofanin-linefilter,totherecorder,displayorprocessor.Changesinanyaspectoftheequipmentorerrorsatanystepintheprocesscanaffecttheaccuracyoftheresults.Forexample,iftheBTPScorrectionfactoriswrong,anaccuratelymeasuredFVCwillbeincorrectlyreported.M.R.MILLERETAL.STANDARDISATIONOFSPIROMETRYEUROPEANRESPIRATORYJOURNALVOLUME26NUMBER2 SpirometersandPEFmetersarenotrequiredtomeasurealloftheindicesintable6,butmustmeettherecommendationsforthosethataremeasured.Accuracyandrepeatabilityrecom-mendationsapplyovertheentirevolumerangeoftheBTPScorrectionAllspirometryvaluesshouldbereportedatBTPSbyanymethod(measuringtemperatureandbarometricpressure)proveneffectivebythemanufacturer.Forvolume-typespirom-eters,thetemperatureinsidethespirometershouldbemea-suredforeachbreathingmanoeuvre.RegardlessoftheBTPScorrectiontechniqueused,theambienttemperaturemustalwaysberecordedwithanaccuracyofC.Insituationswheretheambientairtemperatureischangingrapidly(Cin30min),continuoustemperaturecorrectionsmaybeneces-sary.Spirometerusersshouldbeawareofpotentialproblemswithtestingperformedatlowerambienttemperatures:17Cisthelowerlimit[5563]forambienttemperature,unlessamanufacturerstatesthattheirspirometerwilloperateaccuratelyatlowerambienttemperatures.IfbarometricpressureisnotusedincalculatingtheBTPScorrectionfactor,therangeofbarometricpressuresoverwhichtheBTPScorrectionfactorisvalidmustbepublishedbythemanufacturer.Therationaleforthisrecommendationisbased,inpart,ontheproblemswithfinitecoolingtimesofgasesinvolume-typespirometers[5557]andtheproblemsofestimatingBTPScorrectionfactorsforflowdevices[5860].WhenasubjectperformsanFVCmanoeuvre,theairleavingthelungsisC[61,62]andsaturatedwithwatervapour.IftheexpiredgasisassumedtobeatBTPS,anerrorof1%willresult.Mostvolume-typespirometersassumeinstantaneouscoolingoftheairasitentersthespirometer.Thisisnotalwaysthecase,andcanbeincorrectlyreportedbecauseofit.Forcapillaryandscreenpneumotachometers,thesignaldependsongasviscosity,whichincreaseswithincreasingtemperature.Therefore,forpneumotachometers,adifferentcorrectionfactorisneededforrecordingpatientsascomparedwithrecordingfromthecalibratingsyringe.Also,correctionfactorswillbedifferentforinspiratoryandexpiratorymanoeuvres.Itisusuallyassumedthatexpiredgasdoesnotcoolasitpassesthroughtheflowsensor.Thismaynotbethecase,particularlywithunheatedflowsensors[58,59].Theerrorwillincreaseiftheflowsensorislocatedfurtherfromthemouthandmorecoolingoccurs,asisthecasewhenafilterisplacedinfrontoftheflowsensor.Watercondensationwithinoronthesurfacesofaflowsensormayalteritscalibration.Dependingonenvironmentaltemperature,theBTPScorrectionfactormaybeaslargeas10%.Themethodusedtocalcul
ateorestimatetheBTPSfactorcanpotentiallyintroducesignificanterrors;examplesandafullerexplanationcanbefoundelsewhere[3,4].Changesinspirometertemperaturecanbeasourceofvariability.Spirometertemperatureshouldbemeasuredandnotassumedtobeconstant,evenoverthecourseofonetesting TABLE6RangeandaccuracyrecommendationsspecifiedforforcedexpiratorymanoeuvresTestRange/accuracy(BTPS)FlowrangeTimesResistanceandbackpressureTestsignal0.58L,3%ofreadingor0.050L,whicheverisgreater014303-LCalibrationsyringeFVC0.58L,3%ofreadingor0.050L,whicheverisgreater014151.5cmH(0.15kPa24ATSwaveforms,3-LCalSyringe0.58L,3%ofreadingor0.050L,whicheverisgreater01411.5cmH(0.15kPa24ATSwaveformsTimezeroThetimepointfromwhichallFEVmeasurementsaretakenBackextrapolation10%ofreadingor0.30L(20L),whicheverisgreater;repeatability:5%ofreading0.15L(10L),whicheverisgreater014Meanresistanceat200,400,600L(3.3,6.7,10Lmustbe2.5cmH(0.25kPa26ATSflowwaveformsInstantaneousflows(exceptPEF)5%ofreadingor0.200L,whicheverisgreater1.5cmH(0.15kPaDatafrommanufacturers7.0L5%ofreadingor0.200L,whicheverisgreater1415SameasFEV24ATSwaveforms250Lof2Lwithin10%ofreadingor15Lwhicheverisgreater14(3%)12151.5cmH(0.15kPaSinewavepumpBTPS:bodytemperatureandambientpressuresaturatedwithwatervapour;VC:vitalcapacity;FVC:forcedvitalcapacity;ATS:AmericanThoracicSociety;FEV:forcedexpiratoryvolumeinonesecond;FEV:forcedexpiratoryvolumeintseconds;PEF:peakexpiratoryflow;FEF:meanforcedexpiratoryflowbetween25%and75%ofFVC;MVV:maximumvoluntaryventilation;:tidalvolume.STANDARDISATIONOFSPIROMETRYM.R.MILLERETAL.VOLUME26NUMBER2EUROPEANRESPIRATORYJOURNAL session.Forvolumespirometers,errorsupto6%inFEVFVCcanoccurifambienttemperatureisusedinsteadofinternalspirometertemperature[64].Forvolumespirometers,thetemperatureinsidethespirometershouldbemeasuredforeachbreathingmanoeuvre.TestsignalsforspirometertestingThediversityofFVCmanoeuvresencounteredinclinicalpracticeiscurrentlybestsimulatedbythe24standardvolumetimewaveformsdevelopedbytheATS[3]andHANKINSONARDNER[65].Thesewaveformscanbeusedtodriveacomputer-controlledmechanicalsyringe,oritsequivalent,fortestingactualhardwareandsoftware[66,67],or,whenputinadigitalform,theycanevaluateonlythesoftware.Computer-controlledmechanicalsyringes(pumpsystems)usedforvalidationshouldbeaccuratewithin50mL,whichis0.5%oftheirfullrangeupto10LforFVCandFEV.Pumpsystemsmayhaveaccuracyvaluesbetterthanthisformanyprofiles,butreproducelessaccuratelythosetestprofileswithshortDTsandRTstopeakflow[68,69].TheATSspirometrystatement[3]showsthemeasuredvaluesforeachofthe24standardwaveforms.Onrequest,theATScanprovidethesewaveformsinanelectronicformat.AppropriatecorrectionsforusinggasattheambienttemperatureandhumidityinsteadofBTPSmayneedtobemadeforsomemechanicalsyringespirometerAproductionspirometerisconnectedtothepumpsystemfortesting,orientatedasitwouldbetotesthumansubjects.Connectingtubingmustbekepttotheminimum(0.300L)andmustnotbedistensible.Ifanin-linefilterisrequiredfortestinghumansubjects,onemustbeincludedwhentheinstrumentistested.Eachofthe24ATSwaveformsisdischargedintothespirometerfivetimesunderambientconditions,andallofthereadingsarerecorded.BTPSconditionsaresimulatedbydischargingwaveforms14tothespirometerthreetimes,usingairheatedto37Cand98%relativehumidity.Thetimebetweeneachofthethreetestsshouldbe2min.AccuracytestTheaverageofthefivetestsunderambientconditionsiscomparedwiththestandardvalueinthefollowingway:PercentagedeviationTheaccuracyvalidationlimitsforvolumes,whichincludethewaveform-generatorinaccuracy,are3.5%ofreadingor0.100L,whicheverisgreater.Anaccuracyerroroccursifthedeviation(forvolumes2.857L)orpercentagedeviation(forvolumes2.857L)exceedtheselimits.Theselimitsincludetheallowableinaccuracyofthepumpsystem.AcceptablespirometerperformanceisdefinedasfewerthanthreeaccuracyerrorsforeitherFVCorFEVacrossthe24waveforms(5%errorrate).TheaverageFVCandFEVvaluesofthethreetestssimulatingBTPSconditionsarecomparedwiththestandardvalues.Thevalidationlimitsfortheset
estsunderBTPSconditionsare4.5%or0.200L,whicheveristhegreater,andtheselimitsincludetheallowableinaccuracyforthepumpsystem.AcceptablespirometerperformanceunderBTPSconditionsisdefinedastheaccuracyrequirementbeingmetforallofthefourprofilesused.RepeatabilitytestTheFEVandFVCdatafromtheaccuracytestareusedtoderivethespanofthefiverecordings:PercentagespanTherepeatabilityvalidationlimitsforthevolumemeasuredatambientconditionsare3.5%or0.100L,whicheveristhegreater,and,forBTPSconditions,4.5%or0.200L,whicheveristhegreater.Arepeatabilityerroroccursifthespan(forvolumes2.857Latambientor4.444LatBTPS)orpercentagespan(forvolumesabovethis)exceedstheselimits.AcceptablespirometerperformanceforrepeatabilityunderambientconditionsisdefinedasfewerthanthreeaccuracyerrorsforeitherFVCorFEVacrossthe24profiles(5%errorrate).ForBTPSconditions,theacceptablespirometerperfor-manceforrepeatabilityisdefinedastheaccuracyrequirementbeingmetforallofthefourprofiles.TestsignalsforPEFmetertestingThe26flowtimeATSwaveformswerechosentorepresentarangeofPEFprofilessuitablefordeliverybymechanicalsyringeorpumpsystemstotestPEFmeters[3].Therangeofprofilesandmethodofdeliverymayneedtoberevised,asresearchonPEFmeasurementcontinues[45].ThemechanicalsyringeorsuitablepumpsystemusedtovalidatePEFmeasuringequipmentmusthaveanaccuracyof2%indeliveringPEF.Pumpsystemsmayhavedifficultymeetingthisaccuracystandardforprofilesmoredemandingthanthesetof26[68,69].RecentevidencesuggeststhatthefrequencycontentinthefirstsecondoftheblowthatcontributestoPEFishigher[47]thanpreviouslydetermined[70,71].The26waveformsmaynotcovertherangeofRTandDTfoundin25%oftheclientpopulation[72],and,hence,moredemandingtestprofilesmayberequiredinfuture[45].Tworandomlychosenproductionmodelsoftheflowmetersshouldeachhavethe26waveformsdeliveredtothemfivetimesunderambientconditionsandthereadingsrecorded.AnywaveformswithaPEFoutsidethemetersstatedoperationalrangewouldnotbeincludedinthetestingsequence.AppropriatecorrectionfactorsfortestingunderambientconditionsshouldbeappliedasrecommendedbytheAccuracytestTheaveragereadingforeachofthetwometersiscomparedwiththestandard,asforvolumes.Theaccuracyvalidationlimitsare12%or25Lwhicheveristhelarger,andtheselimitsincludethe2%inaccuracylimitforthewaveformgenerator.AnaccuracyerrorM.R.MILLERETAL.STANDARDISATIONOFSPIROMETRYEUROPEANRESPIRATORYJOURNALVOLUME26NUMBER2 foragivenmeterandgivenwaveformoccursifthedeviationandpercentagedeviationexceedtheselimits.Acceptableperformanceisdefinedasfewerthanthreeaccuracyerrorsoutofthetotalof52tests(26waveforms,twometers).RepeatabilitytestFlowwaveforms1,4,8and25aredischargedthreetimestoeachof10productionmeters.Therepeatabilityvalidationlimitsare6%or15L,whicheveristhegreater,andtheselimitsinclude1%forwaveform-generatorvariability.Arepeatabilityerroroccursifthespanandpercentagespanexceedtheselimits.Acceptableperformanceisdefinedassixorfewererrorsinthe120tests(maximumerrorrateof5%).TestsignalsforMVVtestingAspirometrysystemusedtomeasureMVVshouldbetestedunderambientconditionswithapumpproducingasinusoidalwaveform,withstrokevolumesupto2Lusingthefourpatternsofdeliverypreviouslyspecified[3].TestingatBTPSisnotrequired,andeachpatternistestedtwice.TheaccuracyvalidationlimitsofthespirometerusedformeasuringMVVwithflowsupto250L10.5%ofreadingor20L,whicheverisgreater.Thepressureatthemouthpiecemustnotexceed10cmHO(1kPa)atanypointduringMVVtesting.Theserequirementsapplytovolumespirometersthroughouttheirvolumerange.Acceptableperformanceisdefinedasnoerrorsintheeighttests(fourpatterns,twice).Table7containsalistofabbreviationsandtheirmeanings,whichwillbeusedinthisseriesofTaskForcereports. TABLE7ListofabbreviationsandmeaningsAmbienttemperature,ambientpressure,anddryAmbienttemperatureandpressuresaturatedwithwatervapourBodytemperature(C),ambientpressure,saturatedwithwatervapourCentigradeCFCChlorofluorocarbonsCentimetresCOHbCarboxyhaemoglobinDiffusingcapacityforthelungsmeasuredusingcarbonmonoxide,alsoknownastransferfactorDiffusingc
apacityforcarbonmonoxideperunitofalveolarvolume,alsoknownasMembrane-diffusingcapacityDwelltimeofflow90%ofPEFExpiratoryflowlimitationExpiratoryreservevolumeBackextrapolatedvolumeExpiratoryvitalcapacityFractionofgasXinthealveolargasAlveolarfractionofgasXattimetMeanforcedexpiratoryflowbetween25%and75%ofFVCInstantaneousforcedexpiratoryflowwhenX%oftheFVChasbeenexpired ForcedexpiratoryvolumeinonesecondForcedexpiratoryvolumeintsecondsFractionofexpiredgasXInstantaneousforcedinspiratoryflowatthepointwhereX%oftheFVChasbeeninspiredFractionofinspiredgasXForcedinspiratoryvitalcapacityFunctionalresidualcapacityForcedvitalcapacityHertz;cyclespersecondInspiratorycapacityInspiratoryvitalcapacityTransfercoefficientofthelung(LitresperminuteLitrespersecondPoundsweightMaximalinstantaneousforcedexpiratoryflowwhereX%oftheFVCremainstobeexpiredMaximumflowvolumeloopMaximalinspiratoryflowMaximummid-expiratoryflowMaximumvoluntaryventilationAlveolaroxygenpartialpressureBarometricpressurePeakexpiratoryflowWatervapourpartialpressureInspiredoxygenpartialpressureSpecificuptakeofCObythebloodRisetimefrom10%to90%ofPEFResidualvolumeStandardtemperature(273K,0C),pressure(101.3kPa,760mmHg)anddryTGV(orThoracicgasvolumeTimetakenforinspirationTotallungcapacityTracergasTotaltimeofrespiratorycycleAlveolarvolumeEffectivealveolarvolumeVitalcapacityPulmonarycapillarybloodvolumeDeadspacevolumeInspiredvolumeVolumeoftheexpiredsamplegas TABLE7 STANDARDISATIONOFSPIROMETRYM.R.MILLERETAL.VOLUME26NUMBER2EUROPEANRESPIRATORYJOURNAL ProposalforastandarddataformatforspirometryThisproposalwouldnotprecludetheuseofotherdataformats,butwouldrequirethataspirometershouldatleastbeabletooutputdataintherequiredformat.Theadvantageofastandardformatistheeaseofmovingdataintodatarepositories,suchasqualitycontrol,healthcareandresearchdatabases.Itshouldsimplifyandreducethecostofdatatransferwhenuserschangeinstrumentmodelsandmanufac-turers.Easiertransferofdataintohealthcaredatabaseshasthepotentialforimprovingtheutilityoflungfunctionbymakingmorecompletedatareadilyavailabletocliniciansandhealthcareresearchers.Inresearchandclinicalsettings,astandarddataformatshouldsimplifyandreducethecostoftransferringdataintoqualitycontrolsoftwareandcouldcontributetoimprovedoveralltestquality.Finally,itistimeforthischange;pulmonaryfunctionisoneofthelastmedicalarenaswithoutastandarddataformat.ProposedformatThespirometrydatafilewillconsistofanAmericanStandardCodeforInformationInterchange,comma-delineatedfilewithvariablelengthrecords.Comma-delineatedtextfilesareeasilygeneratedandarestandardimportformatsforseveraldatabaseprograms.Althoughsomeredundancieswillexist,eachrecordshallrepresentonecurveandwillbeterminatedwithacarriagereturnandlinefeed.TheATSwilldistributeexamplesofthisdataformatfromtheirwebsite.Table8showsalistofparametersthatmustbeincludedineveryrecord.Ifaparameterisunavailable,thespacemustremainblank(,,).Theflowtimedatapointsmustbeprovidedwithasamplingintervalof0.01s(100samplesinmL.Ifnecessary,interpolationorothertechniquesmust TABLE8ListofparametersID(patientidentification)PatientnameDatatype(SPfollowedbyEexpiratoryorIInspiratory,followedbySorBbestcurve)Barometricpressure(mmHg)Temperature(C)usedinBTPScalculationRelativehumidity(%)FVCqualityattribute(A,B,C,DorF)qualityattribute(A,B,C,DorF)Effortattribute(A,B,C,DorF)Interpretationcode(seeATSinterpretationscheme)Deletedmanoeuvre(YorN)Acceptablemanoeuvre(YorN)Technicianqualitycontrolcode(A,B,C,DorF)Computerqualitycode(A,B,C,DorF)Plateauachieved(YorN)Review(NorRforneedsrevieworwasreviewed)Dateofreview(DD/MM/YYYY)ReviewerinitialsBTPSfactor(x.xxx)SpirometermanufacturerSpirometermodelSpirometerserialnumberSpirometertype TestingfacilitynameState/regionZip/postcodeCountryE-mailPhonenumberCalibrationdate(DD/MM/YYYY)Calibrationtime(HH:MM)Calibrationresult(PorFforpassedorfailed)Date(DD/MM/YYYY)Time(HH:MM)TechnicianID(technicianidentificationcodeorinitials)ManoeuvrenumberAge(integeryears)Height(
cm)Weight(kg)Sex(MorF)Race(2-characterracecode)Dateofbirth(DD/MM/YYYY)Referencevaluessource(firstauthorsurnameanddateofpublication,Knudson1983)Referencevaluescorrectionfactor(x.xx,1.00fornocorrection)Testingposition(standing,sittingorsupine)Testtype(pre-,post-,bronchodilator,methacholineconcentrationordose)FVC(mL)Extrapolatedvolume(mL)(mL)(mL)PEF(mLVC(mL)Forcedexpiratorytime(s)TimetoPEF(ms)PredictedFVC(mL)PredictedFEVPredictedFEVPredictedFEV/FVC%(xxx.x%)PredictedFEV%(xxx.x%)CommentstextOriginalsamplinginterval(ms)Blank1orFEFBlank2orFEFBlank3orFEFBlank4orFEFBlank5Blank6Blank7Blank8Blank9Blank10NumberofdatapointsFlowdatapoints(mL;variablenumbercontainedinnumberofdatapoints)CarriagereturnLinefeed:Alltexttypevariablesshouldbeenclosedwithdoublequotes()topreventconfusionwithcontrolordataseparatortypecharacteristics. TABLE8M.R.MILLERETAL.STANDARDISATIONOFSPIROMETRYEUROPEANRESPIRATORYJOURNALVOLUME26NUMBER2 M.R.Miller:UniversityHospitalBirminghamNHSTrust,Birmingham,UK;J.Hankinson:HankinsonConsulting,Inc.,Valdosta,GA,USA;V.Brusasco:UniversitadegliStudidiGenova,Genova,Italy;F.Burgos:HospitalClinicVillarroel,Barcelona,Spain;R.Casaburi:HarborUCLAMedicalCenter,Torrance,CA,USA;A.Coates:HospitalforSickChildren,Toronto,ON,Canada;R.CrapoandR.Jensen:LDSHospital,SaltLakeCity,UT,USA;P.Enright:4460EInaRd,Tucson,AZ,USA;C.P.M.vanderGrinten:UniversityHospitalofMaastrict,Maastricht,theNetherlands;P.Gustafsson:QueenSilviasChildrensHospital,Goteborg,Sweden;D.C.Johnson:MassachusettsGeneralHospitalandHarvardMedicalSchool,Boston,MA,USA;N.MacIntyre:DukeUniversityMedicalCenter,Durham,NC,USA;R.McKay:OccupationalMedicine,Cincinnati,OH,USA:D.Navajas:UniversitatdeBarcelona-IDIBAPS,Barcelona,Spain;O.F.Pedersen:UniversityofAarhus,Aarhus,Denmark;R.Pellegrino:AziendaOspedalieraS.CroceeCarle,Cuneo,Italy;G.Viegi:CNRInstituteofClinicalPhysiology,Pisa,Italy;J.Wagner:PharmaceuticalResearchAssociates,Inc.,Lenexa,KS,USA.RenzettiADJr.Standardizationofspirometry.AmRevRespirDis1979;119:831838.AmericanThoracicSociety.Standardizationofspirometry:1987update.AmRevRespirDis1987;136:12851298.AmericanThoracicSociety.Standardizationofspirometry,1994update.AmJRespirCritCareMed1995;152:QuanjerPH,ed.Standardizedlungfunctiontesting.ReportWorkingPartyStandardizationofLungFunctionTests.EuropeanCommunityforCoalandSteel.BullEurPhysiopatholRespir1983;19:Suppl.5,195.QuanjerPH,TammelingGJ,CotesJE,PedersenOF,PeslinR,YernaultJ-C.Lungvolumeandforcedventilatoryflows.ReportWorkingPartyStandardizationofLungFunctionTests,EuropeanCommunityforSteelandCoal.OfficialStatementoftheEuropeanRespiratorySociety.RespirJ1993;6:Suppl.16,540.MorganKC.Theassessmentofventilatorycapacity(committeerecommendations).1975;67:9597.GardnerRM,CrapoRO,BillingsRG,ShigeokaJW,HankinsonJL.Spirometry:whatpaperspeed?84:161165.GardnerRM,ClausenJL,CrapoRO,etal.assuranceinpulmonaryfunctionlaboratories.AmRevRespirDis1986;134:626627.MorrisAH,KannerRE,CrapoRO,GardnerRM.Clinicalpulmonaryfunctiontesting:amanualofuniformlabora-toryprocedures.2ndEdn.SaltLakeCity,UT,IntermountainThoracicSociety,1984.TownsendMC.Theeffectsofleaksinspirometersonmeasurementofpulmonaryfunction.JOccupMed1984;26:AssociationfortheAdvancementofMedicalInstrumentation,Standardforspirometers(draft),October1980.AAMISuite602,1901N.Ft.MyerDrive,Arlington,VA222091699.DAngeloE,PrandiE,Milic-EmiliJ.Dependenceofmaximalflow-volumecurvesontimecourseofprecedingJApplPhysiol1993;75:11551159.StollerJK,BashedaS,LaskowskiD,GoormasticM,McCarthyK.Trialofstandardmodifiedexpirationtoachieveend-of-testspirometrycriteria.AmRevRespir1993;148:275280.BuccaCB,CarossaS,ColagrandeP,etal.Effectofedentulismonspirometrictests.AmJRespirCritCare2001;163:10181020.EigenH,BielerH,GrantD,etal.Spirometricpulmonaryfunctioninhealthypreschoolchildren.AmJRespirCritCareMed2001;163:619623.SmithAA,GaenslerEA.Timingofforcedexpiratoryvolumeinonesecond.AmRevRespirDis1975;112:HorvathEPJr,ed.Manualofspirometryinoccupationalmedicine.Divisi
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