Peter Davis Melbourne Australia Where does HFNC fit in the spectrum of noninvasive ventilation OR THE FACTS MAAM JUST THE FACTS CPAP The Gold Standard RECOMMENDATION CPAP immediately after birth with later selective surfactant administration is an alternative to routine intubat ID: 693305
Download Presentation The PPT/PDF document "High flow nasal cannulae: Evidence base ..." is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
Slide1Slide2
High flow nasal cannulae: Evidence base in preterm infants
Peter Davis
MelbourneAustraliaSlide3
Where does HFNC fit in the spectrum of non-invasive ventilation?
ORSlide4
“THE FACTS MA’AM, JUST THE FACTS”Slide5
CPAP
The Gold StandardSlide6Slide7
RECOMMENDATION
CPAP immediately after birth with later selective surfactant administration is an alternative to routine intubation and surfactant administration in preterm infants (Level of Evidence: 1, Strong Recommendation)
If it is likely that respiratory support with a ventilator will be needed, early administration of surfactant followed by rapid extubation is preferable to prolonged ventilation (Level of
Evidence: 1, Strong Recommendation)Slide8
NCPAP immediately after
extubation
for preventing morbidity in preterm infants
Outcome:
Failure
Study
NCPAP Headbox RR (fixed) RR (fixed)or sub-category n/N n/N 95% CI 95% CI
Engelke 1982
0/9 6/9
0.08 [0.00, 1.19]
Higgins 1991
7/29 23/29
0.30 [0.16, 0.60]
Chan 1993
19/60 22/60
0.86 [0.52, 1.42]
Annibale 1994
15/40 17/42
0.93 [0.54, 1.59]
So 1995
4/25 13/25
0.31 [0.12, 0.81]
Tapia 1995
7/29 2/30
3.62 [0.82, 16.01]
Davis 1998
16/47 27/45
0.57 [0.36, 0.90]
Dimitriou 2000
15/75 25/75
0.60 [0.34, 1.04]
Peake 2005
16/49 24/48
0.65 [0.40, 1.07]
Total (95% CI)
363 363
0.62 [0.51, 0.76]
Total events: 99 (NCPAP), 159 (Headbox)
Test for heterogeneity: Chi² = 17.93, df = 8 (P = 0.02), I² = 55.4%
Test for overall effect: Z = 4.58 (P < 0.00001)
0.1
0.2
0.5
1
2
5
10
Favours NCPAP
Favours Headbox
Treat 6 babies to prevent 1 failureSlide9
HFNC
The ContenderSlide10
The battleground
Primary therapy: prophylaxis/treatment of RDS
Post-extubation care(Apnea)
(Weaning from CPAP)Slide11
WHO IS USING HFNC?
2
/3 of US academic units
Hochwald
,
J of Neonatal-
Perinatal Medicine, 20102/3 of Australia and NZ NICUs Hough, J Paediatr Child Health, 2012>80% of UK NICUsNath, Pediatrics International, 201050% of level 2 and 33% of level 1 SCNs in the UK use HFNC (either humidified or not)Nath, Pediatrics International, 2010
Some tertiary NICUs have stopped using nasal CPAP as routine therapySlide12
Australia NZ Neonatal Network
First included data on HFNC use in 2009
Blended air and oxygen, >1 L/min, ≥4 hoursSlide13
Why are HFNC being used?
‘easy to use’
‘safe’
‘decreases WOB’
‘nurses love it’
‘babies more settled’
‘less “CPAP belly”’‘less nasal trauma’‘no pneumothoraces’Slide14
Nursing Perceptions
Perceptions of HFNC in comparison to NCPAP
Roberts, Journal of Paediatrics and Child Health, 2014Slide15
Nursing Perceptions
Which mode of post-
extubation support would you rather use for these infants?Slide16
Parental Preference
Klingenberg, ADC 2013Slide17
COCHRANE REVIEW (2011)
Wilkinson, Andersen, O’Donnell and De Paoli
“Insufficient evidence to establish the safety or effectiveness of HFNC… in preterm infants”Slide18
COCHRANE REVIEW (2011)
Wilkinson, Andersen, O’Donnell and De Paoli
“Further adequately powered RCTs should be undertaken in preterm infants comparing HFNC with NCPAP…”Slide19
Popularity outstripped the evidenceSlide20
High flow as primary therapySlide21
Yoder, Pediatrics 2013
Multicentre RCT
141 infants (primary therapy) ≥28 weeks and ≥1000g
Randomized in 1
st
24 hrs
HFNC: Comfort Flo, Vapotherm, F&PNCPAP: Bubble, ventilator, SiPAP No significant difference in intubation <72 hours: 9/75 for NCPAP, 6/66 for HFNCSlide22
Kugelman
, Pediatr
Pulmonol 2014 Single centre RCT
76 infants <35 weeks’ gestation
Randomised
to HFNC or NIPPV from birth
No significant difference in intubation13/38 (34.2%) for NIPPV, 11/38 (28.9%) for HFNCSlide23
High flow for Post extubation careSlide24
Collins, J
Pediatr
2012Single centre RCT
Device:
Vapotherm
vs Hudson binasal prongsSubjects: 132 infants <32 weeks, post-extubationPrimary outcome: No significant difference in extubation failure within 7 daysHFNC caused less nasal traumaSlide25
Yoder, Pediatrics 2013
Devices: Comfort Flo, Fisher and
Paykel,
Vapotherm
vs
Bubble CPAP, Infant Flow, VentilatorSubjects: 432 infants 28 weeks – term, primary therapy or post-extubationPrimary outcome: No significant difference in intubation <72 hours HFNC caused less nasal traumaSlide26
NON-INFERIORITY TRIALS
Most RCTs are
superiority
trials
Non-inferiority trials: does the new treatment (eg. HFNC) have efficacy that is similar to or no worse than an established therapy (eg. NCPAP) The premise: the new treatment has some other benefit and might be favoured over the standard treatment, even if the efficacy is the same or lowerPiaggio et al, JAMA 2006Slide27
NON-INFERIORITY TRIALS
Non-inferiority is based on the
risk difference (95% CI)
for the primary outcome between the two treatments
‘Margin of non-inferiority’
is definedWe defined the margin as 20%If the risk difference for treatment failure and upper limit of its 95% CI is ≤20%, then HFNC is ‘non-inferior’ Piaggio et al, JAMA 2006Slide28Slide29
SUPERIORSlide30
NON-INFERIORSlide31
INCONCLUSIVESlide32
INFERIORSlide33
Hi
gh-Flow Nasal Cannulae as
Post-
E
xtubation
R
espiratory Support in Premature Infants:A CPAP Equivalent?A multicenter, randomized, non-inferiority trialNEJM 2013The HIPERSPACE TrialSlide34
INTERVENTION
HFNC
Fisher &
Paykel
‘
Optiflow’ circuitFisher & Paykel prongsExtubated 5-6 L/minMax 6-8 L/minMin 2 L/min
Could use NCPAP only if already failed HFNCNCPAPVentilator or ‘Bubble’ CPAPHudson/midline binasal prongsExtubated 7 cm H2OMax 8 cm H2O
Min 5 cm H
2
O
+/- Non-synchronised NIPPV
Discouraged
any
use of HFNC
during the admission
Caffeine <24 hours prior to extubationSlide35
INTERVENTION
HFNC
Fisher &
Paykel
‘
Optiflow’ circuitFisher & Paykel prongsExtubated 5-6 L/minMax 6-8 L/minMin 2 L/min
Could use NCPAP only if already failed HFNCNCPAPVentilator or ‘Bubble’ CPAPHudson/midline binasal prongsExtubated 7 cm H2OMax 8 cm H2O
Min 5 cm H
2
O
+/- Non-synchronised NIPPV
Discouraged
any
use of HFNC
during the admission
Caffeine <24 hours prior to extubationSlide36
INTERVENTION
HFNC
Fisher &
Paykel
‘
Optiflow’ circuitFisher & Paykel prongsExtubated 5-6 L/minMax 6-8 L/minMin 2 L/min
Could use NCPAP only if already failed HFNCNCPAPVentilator or ‘Bubble’ CPAPHudson/midline binasal prongsExtubated 7 cm H2OMax 8 cm H2O
Min 5 cm H
2
O
+/- Non-synchronized NIPPV
Discouraged
any
use of HFNC
during the admission
Caffeine <24 hours prior to extubationSlide37
PRIMARY OUTCOME
Failure of the assigned treatment within 7 days
Defined as receiving
maximal suppor
t and satisfying
one or mor
e of the following criteria:1. Increased oxygen: increase of 20% (0.2) above pre-extubation baseline2. Apnea: more than 6 requiring stimulation in 6 hours or 2 episodes of positive pressure ventilation in 24 hours3. Respiratory acidosis: pH <7.2 and pCO2 >60 mm Hg
4. Emergency intubation: at physician discretion Slide38
FAILURE
HFNC
FAIL
NCPAP 7 cm H
2
O (+/- nsNIPPV) FAIL RE-INTUBATEDSlide39
FAILURE
HFNC
FAIL
NCPAP 7 cm H
2
O (+/- nsNIPPV) FAIL RE-INTUBATED
‘Rescue CPAP’Slide40
FAILURE
HFNC
FAIL
NCPAP 7 cm H
2
O (+/- nsNIPPV) FAIL RE-INTUBATEDNCPAPFAIL
RE-INTUBATEDSlide41
INFANT DEMOGRAPHICS
HFNC
N=152
NCPAP
N=151
GA, weeks, mean (SD)
27.7 (2.1)
27.5 (1.9)Birth weight, grams, mean (SD)
1041 (338)
1044 (327)
Antenatal corticosteroids
93%
95%
Surfactant treatment
93%
95%
Median age at
extubation
, hours
43
38
Mean FiO
2
prior to extubation
0.23
0.23Slide42
PRIMARY OUTCOME (N=303)
FAILURE OF THE ASSIGNED TREATMENT WITHIN 7 DAYS
HFNC
52/152
34%
NCPAP
39/151 26%Risk difference 8%95% CI (-2, 19) % Slide43
8
19
-2Slide44
NON-INFERIORSlide45
<26 WEEKS’ GA (N=63)
FAILURE OF THE ASSIGNED TREATMENT WITHIN 7 DAYS
HFNC
26/32
81%
NCPAP
19/31 61%Risk difference 20%95% CI (-2, 42) % Slide46
INCONCLUSIVESlide47
26 WEEKS’ GA (N=240)
FAILURE OF THE ASSIGNED TREATMENT WITHIN 7 DAYS
HFNC
26/120
22%
NCPAP20/120 17%Risk difference 5% 95% CI (-5, 15) % Slide48
5
-5
15Slide49
NON-INFERIORSlide50
SECONDARY OUTCOMES:
RE-INTUBATION WITHIN 7 DAYS
HFNC
27/152
18%
NCPAP
38/151 25%
Risk difference -7%95% CI (-17, 2) % Slide51
SECONDARY OUTCOMES:
RE-INTUBATION WITHIN 7 DAYS
HFNC
27/152
18%
NCPAP
38/151 25%
HALF OF INFANTS IN WHOM HFNC FAILED WERE ‘RESCUED’ BY NCPAPSlide52
No difference in:
Death or BPD
Time on resp support
Steroids for BPD
Days in oxygen
Pneumothorax
Laser for ROPProven sepsisNEC stage 2 or 3IVH grade 3 or 4Cystic PVLDays in hospitalSlide53
NASAL TRAUMA
HFNC
NCPAP
P value
Nasal trauma
Any recorded
Due to assigned treatment
39%19%
55%
53%
0.008
<0.001Slide54
CONCLUSIONS
HFNC was non-inferior to NCPAP as post-extubation support in very preterm infants
About half of very preterm infants in whom HFNC therapy failed were ‘rescued’ from re-intubation by NCPAP
HFNC is feasible, but should be used with caution in infants born <26 weeks’ GA
HFNC was not associated with any increased risk of morbidity, and caused less nasal trauma than NCPAPSlide55
HFNC
vs
CPAP/NIPPV as Primary TherapyNeed for intubationSlide56
HFNC
vs CPAP post-extubation
Extubation failureSlide57
But what does it mean for us?
Moved from sceptics to cautious adopters
More mature babiesCPAP back upWe like it for
Kangaroo care (from week 1)
Establishment of breast feeding (and boosting maternal supply) from 32 weeks
We like it enough to start a trial of HFNC for initial therapy of RDS in babies >28 weeks (
HipsterTrial)Slide58
Thank you
to the
Hipsters