Overview and Challenges Jeffrey S Gerdes MD MBA Associate Chair Department of Pediatrics Children s Hospital of Philadelphia Associate Professor Perelman School of Medicine Emidio ID: 233522
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Slide1
Neonatal Non-Invasive Respiratory Support: Overview and Challenges
Jeffrey S. Gerdes, MD, MBAAssociate Chair, Department of PediatricsChildren’s Hospital of PhiladelphiaAssociate Professor, Perelman School of MedicineEmidio M. Sivieri, MSEResearch Bioengineer, CHOP Newborn Care at Pennsylvania HospitalSlide2Slide3
Why Non-Invasive Support?Airway distending pressure to maintain FRC is the cornerstone upon which all other support modalities are built
Less Chronic Lung DiseaseFewer airway complicationsFewer InfectionsReduced inflammationLess stress for babies, families, and staffLower costSlide4
Increasing HFNC UseAll Patients during NICU Stay
Courtesy of Dr. Reese Clark, Pediatrix
All Patients during NICU StaySlide5
NIPPV
SiPapNAVANCPAPNIV using RAM Cannula
HFONC
??????????????????
HFNC
Question
of the day
Mechanisms of Action
Physiologic Rationale
Challenges for Clinical ResearchSlide6
Nasal CPAP: Physiologic RationaleDistending pressure recruits lung volume
Increases and stabilizes FRCSplints upper airways and compliant chest wallImproves lung ComplianceReduces airway ResistanceDecreases Work of BreathingImproves gas exchangeReduces apneaSlide7
NCPAP: Mechanisms of Delivery
Constant flow: flow opposition (conventional vent)Constant flow: liquid seal (bubble)Variable flow: “fluidic flip” (Infant Flow)Patient expiratory flow opposes system flow and an expiratory resistor valve
Expiratory limb submerged in liquid, with oscillatory nature
Inspiratory and expiratory flow compensation via fluidics engineeringSlide8
All NCPAP devices are not created equal
Variable flow reduces WOB compared to conventional vent CPAP (Lipsten et al, J Perinatol 2005)Variable flow may compensate better for mouth or seal leakageBubble oscillations may improve lung recruitment (Pillow et al, Am J Crit Care Med 2007)Bubble CPAP pressure delivery is flow dependent and not reliably delivered relative to liquid depth (Kahn et al, Pediatr Res 2007)Bubble CPAP pressure delivery varies more than variable flow CPAP (Kahn et al, Pediatr 2008)Nasal interfaces vary in resistance to flow (DePaoli et al, Arch Dis Child Fetal Neonatal Ed 2002)
Variable safety regarding alarms and expiratory limb obstruction risk
Examples:Slide9
at 6 L/minPressure-drop across prongs - by manufacturer
RAM (micro-preemie )
RAM (preemie)
RAM (Newborn)
Modified from: De Paoli, Morley, Davis et al. Arch Dis Child Neonatal Ed 2002
(All at 6 L/min Flow)
0
2
4
6
8
21
Pressure drop
(cmH
2
O)Slide10
Effect of mouth leak
3
4
5
6
7
8
8
7
6
5
4
3
2
1
0
Set CPAP
(cm H
2
O)
Pharyngeal pressure
(cm H
2
O)
De Paoli, et al. Arch Dis Child Neonatal Ed 2005Slide11
4
6
8
Bubble Bias Flow
(L/min)
Mean Pressure
(±SD)
(cm H
2
O)
2
10
12
Set CPAP
Bubble CPAP vs. CPAP with Mech. Ventilator
Kahn, Habib, Courtney, Pediatrics 2008
Bubble CPAP pressure is
flow dependent
Bubble CPAP
Ventilator
No Leak
12
10
8
6
4
8
4Slide12
Clinical Correlations of different CPAP Drivers and InterfacesClinical studies often do not offer clear actionable results
Do mechanistic differences matter, or have they not been discoverable with current studies?Babies have widely variable pathophysiology and severity of illnessDo the large pragmatic trials of NIRS strategies deliver specific answers for relative efficacy when the “gold standard” of CPAP is delivered with widely divergent modalities?Slide13
NIPPV or SNIPPV: Physiologic Rationale
Benefits of NCPAP + additional tidal ventilation and/or lung recruitment from higher MAPMay reduce WOB relative to CPAP (Aghai et al, Pediatr Pulmonol 2006; Chang et al, Ped Res 2011) Airway pressures actually delivered vary considerably from settings (Owen et al, Arch Dis Child Fetal Neonat Ed. 2010 )Is variable pressure delivery favorable to lung function?Is apnea Improved through cyclic receptor stimulation?Synchronization may improve efficacyUnclear if NIPPV or bi-level CPAP is more efficacious (Roberts et al, Pediatrics 2013)Are these modalities “Super CPAP”?Slide14
Heated and Humidified High Flow Nasal CannulaSlide15
HFNC: Mechanisms of ActionGas Conditioning EffectsFlow EffectsPressure EffectsSlide16
HFNC: Mechanisms of Action
Gas Conditioning Effects
Reduces patient’s metabolic workload needed for Heating and Humidifying
(Waugh et al, Granger, RespCare 2004)
Improves mechanics
- H&H Increases Compliance and Conductance
(Greenspan et al, J
Peds
1991) Slide17
HFNC: Mechanisms of Action
Flow Effects
Improves lung mechanicsReduced inspiratory resistance => Reduced resistive Work of Breathing
(Saslow et al, J Perinatol 2006)Expiration: possible “Coanda”
effect
(Dysart et al, Resp Med 2009)
Washout of Nasopharyngeal dead space => Improved gas exchange
(Frizzola et al, Pediatr Pulm 2011)
As flow increases, CO
2
elimination > increase in MAP Analogous to Trans Tracheal Catheter TGI
Slide18
Washout of anatomical dead space
Continuous flow washes out the upper airways and leads to improved oxygenation Reservoir of fresh gas in upper airwayAvoids rebreathing of high-CO2 gas in dead spaceSchibler et al, Int Care Med 2011Courtesy of Walsh et al, Resp Care 2009
Nasal cannula
Proposed flushing of
dead space at higher flows
Washout of nasopharyngeal cavity
Washout
flow exiting
the mouthSlide19
HFNC: Mechanisms of ActionPressure Effects
HFNC has been shown to provide positive distending pressureHighly dependent on prong-to-nares diameter ratio and degree of mouth closure (Locke et al, Pediatrics 1993; Sivieri et al, Pediatr Pulm 2013)Slide20
74%
68%
55%
44%
36%
Intra-cannula
pressure (74% occl.)
Pressure Limiting Safety Valve opens
Percent
Occlusion
74%
68%
55%
44%
36%
Percent
Occlusion
100%
86%
Mouth Fully Closed
Mouth Fully Open
HFNC Pressure Delivery:
Effect of flow rate, % nares
occlusion,
and
mouth leak
Sivieri, Gerdes, Abbasi. Pediatr. Pulm. 2013Slide21
HFNC delivered pressure
Pharyngeal Pressure
(cmH
2O)Flow 2 Lpm
Flow 4 Lpm
Flow 6 Lpm
1 minute
Wilkinson et al, J Perinatol 2008Slide22
Causes of variability of delivery of HFNC% nasal occlusion by catheter Characteristics of catheter design
Characteristics of gas conditioning with heat and humidityMouth leakVariability in disease state of the patientSlide23
RAM CannulaTM
(Neotech Products)Soft nasal prong interface, relatively large IDFDA approved as a Class I medical device, as a nasal cannula for delivering oxygen: CPAP interfaces are Class 2 Medical Devices3 sizes: micro-preemie (ID 2.0 ,OD 2.7), preemie (ID 2.0, OD 2.9), newborn (ID 2.5, OD 3.1 )“Expiratory limb” much smaller diameter than CPAP interfacesRecommended % nasal occlusion: 60-80%Connector attaches to standard ventilator tubingHas been used to deliver CPAP, NIMV, HFONVSlide24
RAM Cannula
TM (Neotech Products)Slide25
RAM CannulaTM
(Neotech Products)Soft nasal prong interface, relatively large IDFDA approved as a Class I medical device, as a nasal cannula for delivering oxygen: CPAP interfaces are Class 2 Medical Devices3 sizes: micro-preemie (ID 2.0 ,OD 2.7), preemie (ID 2.0, OD 2.9), newborn (ID 2.5, OD 3.1 )“Expiratory limb” much smaller diameter than CPAP interfacesRecommended % nasal occlusion: 60-80%Connector attaches to standard ventilator tubingHas been used to deliver CPAP, NIMV, HFONVSlide26
`
100%
100%
78%
60%
48%
38%
Percent Occlusion
Mouth Fully Closed
Mouth Fully Open
RAM Cannula Pressure Delivery:
Bench Test
Gerdes, Sivieri, Abbasi, EAPS Congress 2014
Dräger BabyFlow M prongs 4.5mm O.D.
RAM Preemie Cannula 3.1 mmO.D. prongs
Nares
I.D.Slide27
RAM Cannula used for “NCPAP”
In bench tests, RAM cannula interface delivers 60% less than the MAP set on the ventilator, even with mouth closedWith mouth open, delivered MAP is further reducedBy design, RAM cannula is neither NCPAP nor HFNCUsing 60-80% nares occlusion does not provide sufficient seal to deliver CPAP.Due caution should be applied if using RAM cannula interface to provide CPAP, pending further studies and classification as a Class II Medical DeviceSlide28
Nasal High Frequency Ventilation
Initial pCO
2
Final pCO
2
2 hours NHFV
pCO
2
(mm Hg)
75
70
65
60
55
50
45
40
35
30
Colaizy
et al,
Acta
Paediatr
. 200
Infant Star,
Single Nasopharyngeal tube
Frequency 10Hz
Amplitude 50
torr
n=14 Infants
GA 27 (25-30) wks
BW 1.6 (1.1-2.9) kg
p = 0.011Slide29
NIPPV
SiPapNAVANCPAPNIV using RAM Cannula
HFONC
Mechanisms of Action
Physiologic Rationale
Challenges for Clinical Research
Does it matter which NIRS strategy is used in a given patient or NICU?
HFNC
Question
of the daySlide30
Pulmonary Factors to Consider When Evaluating NIRS Systems
Physiologic mechanisms imply that: - NCPAP/NIPPV might be better for lung recruitment- HFNC might be better for CO2 retention- NIPPV might be better for apneaAre we reasonably able to study these differences, And are these differences clinically important?BUTSlide31
Extra-pulmonary Factors to Consider When Evaluating NIRS Systems
Minimizing nasal septal injuryEase of nursing and respiratory therapy careComfort for baby and familyNoise pollutionPromotion of infant developmentCost –interface and disposables, amortized cost of the driver, RRT and RN time, and possible impacts on length of stay or severity of illnessSlide32
NIRS: Summary and Challenges for this conferenceNCPAP, NIPPV, and HFNC all have physiologic rationales and feasible mechanisms of action
All provide varying degrees of respiratory support which improve physiologic parameters and gas exchange in neonatesLittle is known about which devices may be better for different patho-physiologies or different severities of illnessDo the clinical trials have sufficient numbers or stratification of diagnoses and severity of illness to differentiate the utility of these modalities? OR,Slide33
Are we left with the current state in which clinicians apply well-studied, safe NIRS techniques according to unit or provider preference, matching the device to the baby’s needs, and response to therapy?Are “more randomized trials” the answer, or should we steer towards other research methodologies?
NIRS: Summary and Challenges for this conference