High Flow Nasal Cannula Therapy as an Alternative to

Transcription

High Flow Nasal Cannula Therapy as an Alternative to
High Flow Nasal Cannula Therapy as an Alternative to Nasal Continuous Positive Airway
Pressure in Preterm Infants: A Pooled Analysis
Richard H. Speicher, MD1,2; Steven L. Shein, MD1,2; David H. Speicher, MD1,2; Alexandre T. Rotta, MD 1,2
(1)Pediatric Critical Care, UH Rainbow Babies & Children’s Hospital, Cleveland, OH; (2)Department of Pediatrics, Case Western Reserve University, Cleveland, OH
INTRODUCTION
RESULTS
RESULTS
• Heated, humidified high flow nasal cannula (HFNC) therapy has
• Of the five included trials, four compared nasal CPAP vs. HFNC
increasingly gained acceptance as a treatment modality in neonatal
intensive care units worldwide.
• HFNC has been shown to be safe and convenient to use in the
pediatric population, and compares favorably to nasal continuous
positive airway pressure (CPAP) with respect to the occurrence of nasal
trauma.
• Recent prospective clinical trials in premature infants demonstrate
non-inferiority of HFNC compared to CPAP for clinically relevant
endpoints such as intubation.
• A pooled analysis of these studies may show superiority of one
modality, or suggest variables associated with treatment success, such
as the use of particular HFNC devices.
Trial
Collins
J Peds 2013
Yoder
Pediatrics 2013
Manley
NEJM 2013
Lavizzaru
PAS 2013
Miller
J Perinatol 2010
Subjects
Endpoint
Device
Reintubation
at 7 days
28 to 42 wks Reintubation
at 72 hrs
< 32 wks
Reintubation
at 7 days
29 to 36 wks Reintubation
at 72 hrs
26 to 29 wks Reintubation
at 72 hrs
Vapotherm
< 32 wks
Vapotherm,
F&P, Hudson
F&P
Vapotherm
Vapotherm,
F&P
- Fisher & Paykel Healthcare [Irvine, CA]
- Hudson RCI [Research Triangle Park, NC]
- Vapotherm Inc. [Stevensville, MD])
• One trial compared two HFNC devices
- Fisher & Paykel Healthcare HFNC
- Vapotherm HFNC
• A total of 998 patients were analyzed, with 510 randomized to the
HFNC group and 488 randomized to the CPAP group.
• Both the HFNC and CPAP groups had similar rates of meeting the
primary failure endpoint (19.6% vs. 16.8%, risk ratio=1.167, 95%
CI=0.895-1.512, p=0.252).
• Of the 510 patients randomized to HFNC, 181 were treated with the
• We hypothesized that HFNC therapy would not be inferior to nasal
Vapotherm device, 17 with the Hudson RCI device and 312 with the
CPAP and that type of device utilized would not affect outcome in
Fisher & Paykel Healthcare device.
premature infants.
METHODS
• Medline and Google Scholar database searches to identify
contemporary prospective randomized controlled trials of HFNC therapy
in premature infants.
Outcome
Nasal CPAP, n (%)
HFNC, n (%)
Failure
Success
82 (16.8%)
406 (83.2%)
100 (19.6%)
410 (80.4%)
Total
488 (100%)
510 (100%)
Risk Ratio= 1.167, 95% CI= 0.895 – 1.512, p= 0.252
•Five clinical trials met inclusion criteria and had sufficient detail to
•The outcome variable was the predetermined primary outcome
(treatment failure, such as need for intubation) specifically set for each
individual trial.
•Data were analyzed with dedicated software (MedCalc Software
Version 13.2, Ostend, Belgium).
•A p<0.05 was considered statistically significant.
the primary failure endpoint was significantly lower for the Vapotherm
system (14.4%) compared to other devices (22.5%, risk ratio=0.639,
95% CI=0.4245–0.9608, p=0.031).
DISCLOSURE
CONCLUSIONS
• HFNC therapy and nasal CPAP appear to have similar efficacy in
permit a pooled analysis: Miller, J Perinatol 2010; Collins, JPeds 2013;
Manley, NEJM 2013; Yoder, Pediatrics 2013; Lavizzari, PAS 2013.
• When data were analyzed based on device type, the rate of meeting
Outcome
Vapotherm, n (%)
Others, n (%)
Failure
Success
26 (14.4%)
155 (85.6%)
74 (22.5%)
255 (77.5%)
Total
181 (100%)
329(100%)
preventing respiratory failure in premature infants.
• Our data suggest that the device used to deliver HFNC may influence
outcome and this warrants further prospective investigation.
Risk Ratio= 0.6386, 95% CI= 0.4245 – 0.9608, p= 0.031
ATR is a scientific advisory board member for Vapotherm, Inc.