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Published on: March 14, 2013
A Randomized Trial of High-Flow Oxygen Therapy in Infants with Bronchiolitis
Donna Franklin1, Franz E Babl1, Luregn J Schlapbach1
1From the Pediatric Critical Care Research Group, Centre for Children's Health Research, Lady Cilento Children's Hospital, and Mater Research Institute (D.F., L.J.S., A.S.), the Schools of Medicine (D.F., L.J.S., J.F.F., A.S.) and Public Health (M.J.), University of Queensland, and the Critical Care Research Group, Adult Intensive Care Service, Prince Charles Hospital (D.F., J.F.F.), Brisbane, the Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, VIC (D.F., F.E.B., E.O., S.C., J.N., J.F., S.R.D., A.S.), Royal Children's Hospital, the Emergency Department, Murdoch Children's Research Institute, and the Department of Paediatrics, Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne, Melbourne, VIC (F.E.B., E.O.), the Department of Medicine, School of Clinical Sciences, Monash University, and the Paediatric Emergency Department, Monash Medical Centre, Monash Health, Clayton, VIC (S.C.), and the College of Medicine and Dentistry, James Cook University, and the Emergency Department, Townsville Hospital, Townsville, QLD (J.F.) - all in Australia; the Department of Pediatrics, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland (L.J.S.); KidzFirst Middlemore Hospital and the University of Auckland (J.N.) and the Children's Emergency Department, Starship Children's Hospital, and Liggins Institute, University of Auckland (S.R.D.), Auckland, New Zealand; and Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom (J.A.W.).
Insights
High-flow oxygen therapy significantly reduced the need for escalated care in infants with bronchiolitis outside the intensive care unit (ICU). This treatment proved more effective than standard oxygen therapy in preventing worsening symptoms and interventions.
Area of Science:
- Pediatrics
- Respiratory Medicine
- Clinical Trials
Background:
- High-flow oxygen therapy via nasal cannula is increasingly used for infant bronchiolitis.
- Evidence for its efficacy outside intensive care units (ICUs) is limited.
- The study addresses the unclear efficacy in non-ICU settings.
Purpose of the Study:
- To evaluate the efficacy of high-flow oxygen therapy compared to standard oxygen therapy in infants with bronchiolitis.
- To determine if high-flow oxygen therapy reduces escalation of care in non-ICU settings.
- To assess secondary outcomes including hospital stay duration and adverse events.
Main Methods:
- A multicenter, randomized, controlled trial involving 1472 infants younger than 12 months with bronchiolitis.
- Infants received either high-flow oxygen therapy or standard oxygen therapy, with rescue high-flow available for treatment failure.
- Primary outcome was escalation of care; secondary outcomes included hospital stay, oxygen duration, ICU admission, and intubation.
Main Results:
- Escalation of care occurred in 12% of the high-flow group versus 23% in the standard-therapy group (P<0.001).
- No significant differences in hospital stay or oxygen therapy duration were found.
- One case of pneumothorax occurred in each group; 61% of standard-therapy failures responded to rescue high-flow therapy.
Conclusions:
- High-flow oxygen therapy significantly lowered escalation of care rates in non-ICU infants with bronchiolitis.
- The findings support the use of high-flow oxygen therapy in this population.
- Rescue high-flow therapy was effective for a majority of treatment failures in the standard-therapy group.
Background:
High-flow oxygen therapy through a nasal cannula has been increasingly used in infants with bronchiolitis, despite limited high-quality evidence of its efficacy. The efficacy of high-flow oxygen therapy through a nasal cannula in settings other than intensive care units (ICUs) is unclear.
Methods:
In this multicenter, randomized, controlled trial, we assigned infants younger than 12 months of age who had bronchiolitis and a need for supplemental oxygen therapy to receive either high-flow oxygen therapy (high-flow group) or standard oxygen therapy (standard-therapy group). Infants in the standard-therapy group could receive rescue high-flow oxygen therapy if their condition met criteria for treatment failure. The primary outcome was escalation of care due to treatment failure (defined as meeting ≥3 of 4 clinical criteria: persistent tachycardia, tachypnea, hypoxemia, and medical review triggered by a hospital early-warning tool). Secondary outcomes included duration of hospital stay, duration of oxygen therapy, and rates of transfer to a tertiary hospital, ICU admission, intubation, and adverse events.
Results:
The analyses included 1472 patients. The percentage of infants receiving escalation of care was 12% (87 of 739 infants) in the high-flow group, as compared with 23% (167 of 733) in the standard-therapy group (risk difference, -11 percentage points; 95% confidence interval, -15 to -7; P<0.001). No significant differences were observed in the duration of hospital stay or the duration of oxygen therapy. In each group, one case of pneumothorax (<1% of infants) occurred. Among the 167 infants in the standard-therapy group who had treatment failure, 102 (61%) had a response to high-flow rescue therapy.
Conclusions:
Among infants with bronchiolitis who were treated outside an ICU, those who received high-flow oxygen therapy had significantly lower rates of escalation of care due to treatment failure than those in the group that received standard oxygen therapy. (Funded by the National Health and Medical Research Council and others; Australian and New Zealand Clinical Trials Registry number, ACTRN12613000388718 .).
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