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Original Investigation
Caring for the Critically Ill Patient
June 16, 2022

Effect of High-Flow Nasal Cannula Therapy vs Continuous Positive Airway Pressure Therapy on Liberation From Respiratory Support in Acutely Ill Children Admitted to Pediatric Critical Care Units: A Randomized Clinical Trial

Author Affiliations
  • 1Section of Anaesthetics, Pain Medicine, and Intensive Care, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, England
  • 2Children’s Acute Transport Service, Great Ormond Street Hospital for Children NHS Foundation Trust, London, England
  • 3Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, England
  • 4Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, England
  • 5parent representative, Sussex, England
  • 6Birmingham Children’s Hospital, Birmingham Women’s and Children’s NHS Foundation Trust, Birmingham, England
  • 7Institute of Applied Health Research, University of Birmingham, Birmingham, England
  • 8School of Health and Society, University of Salford, Salford, England
  • 9Paediatric Intensive Care Unit, Bristol Royal Hospital for Children, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, England
  • 10Paediatric Intensive Care Unit, Great Ormond Street Hospital for Children NHS Foundation Trust and NIHR Biomedical Research Centre, London, England
  • 11University College London Great Ormond Street Institute of Child Health, London, England
  • 12Leeds Institute for Data Analytics, School of Medicine, University of Leeds, Leeds, England
JAMA. 2022;328(2):162-172. doi:10.1001/jama.2022.9615
Visual Abstract. Effect of HFNC vs CPAP Therapy on Liberation From Respiratory Support in Acutely Ill Children
Effect of HFNC vs CPAP Therapy on Liberation From Respiratory Support in Acutely Ill Children
Key Points

Question  In acutely ill children clinically assessed to require noninvasive respiratory support in a pediatric critical care unit, is first-line use of high-flow nasal cannula therapy (HFNC) noninferior to continuous positive airway pressure (CPAP) in terms of time to liberation from all forms of respiratory support?

Findings  In this randomized noninferiority trial of 600 acutely ill children clinically assessed to require noninvasive respiratory support, median time to liberation was 52.9 hours for HFNC vs 47.9 hours for CPAP. The 1-sided 97.5% confidence limit for the hazard ratio was 0.86, falling within the noninferiority margin of 0.75.

Meaning  Among acutely ill children clinically assessed to require noninvasive respiratory support in a pediatric critical care unit, HFNC met the criterion for noninferiority compared with CPAP for time to liberation from respiratory support.

Abstract

Importance  The optimal first-line mode of noninvasive respiratory support for acutely ill children is not known.

Objective  To evaluate the noninferiority of high-flow nasal cannula therapy (HFNC) as the first-line mode of noninvasive respiratory support for acute illness, compared with continuous positive airway pressure (CPAP), for time to liberation from all forms of respiratory support.

Design, Setting, and Participants  Pragmatic, multicenter, randomized noninferiority clinical trial conducted in 24 pediatric critical care units in the United Kingdom among 600 acutely ill children aged 0 to 15 years who were clinically assessed to require noninvasive respiratory support, recruited between August 2019 and November 2021, with last follow-up completed in March 2022.

Interventions  Patients were randomized 1:1 to commence either HFNC at a flow rate based on patient weight (n = 301) or CPAP of 7 to 8 cm H2O (n = 299).

Main Outcomes and Measures  The primary outcome was time from randomization to liberation from respiratory support, defined as the start of a 48-hour period during which a participant was free from all forms of respiratory support (invasive or noninvasive), assessed against a noninferiority margin of an adjusted hazard ratio of 0.75. Seven secondary outcomes were assessed, including mortality at critical care unit discharge, intubation within 48 hours, and use of sedation.

Results  Of the 600 randomized children, consent was not obtained for 5 (HFNC: 1; CPAP: 4) and respiratory support was not started in 22 (HFNC: 5; CPAP: 17); 573 children (HFNC: 295; CPAP: 278) were included in the primary analysis (median age, 9 months; 226 girls [39%]). The median time to liberation in the HFNC group was 52.9 hours (95% CI, 46.0-60.9 hours) vs 47.9 hours (95% CI, 40.5-55.7 hours) in the CPAP group (absolute difference, 5.0 hours [95% CI –10.1 to 17.4 hours]; adjusted hazard ratio 1.03 [1-sided 97.5% CI, 0.86-∞]). This met the criterion for noninferiority. Of the 7 prespecified secondary outcomes, 3 were significantly lower in the HFNC group: use of sedation (27.7% vs 37%; adjusted odds ratio, 0.59 [95% CI, 0.39-0.88]); mean duration of critical care stay (5 days vs 7.4 days; adjusted mean difference, −3 days [95% CI, −5.1 to −1 days]); and mean duration of acute hospital stay (13.8 days vs 19.5 days; adjusted mean difference, −7.6 days [95% CI, −13.2 to −1.9 days]). The most common adverse event was nasal trauma (HFNC: 6/295 [2.0%]; CPAP: 18/278 [6.5%]).

Conclusions and Relevance  Among acutely ill children clinically assessed to require noninvasive respiratory support in a pediatric critical care unit, HFNC compared with CPAP met the criterion for noninferiority for time to liberation from respiratory support.

Trial Registration  ISRCTN.org Identifier: ISRCTN60048867

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