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- Title
Effect of Early High-Flow Nasal Oxygen vs Standard Oxygen Therapy on Length of Hospital Stay in Hospitalized Children With Acute Hypoxemic Respiratory Failure: The PARIS-2 Randomized Clinical Trial.
- Authors
Franklin, Donna; Babl, Franz E.; George, Shane; Oakley, Ed; Borland, Meredith L.; Neutze, Jocelyn; Acworth, Jason; Craig, Simon; Jones, Mark; Gannon, Brenda; Shellshear, Deborah; McCay, Hamish; Wallace, Alexandra; Hoeppner, Tobias; Wildman, Mark; Mattes, Joerg; Pham, Trang M. T.; Miller, Letitia; Williams, Amanda; O'Brien, Sharon
- Abstract
Key Points: Question: Does the early use of nasal high-flow oxygen therapy in children aged 1 to 4 years with acute hypoxemic respiratory failure reduce the length of hospital stay compared with standard oxygen therapy? Findings: In this randomized clinical trial that included 1567 children with acute hypoxemic respiratory failure, use of nasal high-flow oxygen therapy resulted in a median hospital stay of 1.77 days compared with 1.50 days in the standard oxygen therapy group, a difference that was statistically significant. Meaning: Early use of nasal high-flow oxygen therapy in children aged 1 to 4 years with acute hypoxemic respiratory failure did not reduce the length of hospital stay compared with standard oxygen therapy. Importance: Nasal high-flow oxygen therapy in infants with bronchiolitis and hypoxia has been shown to reduce the requirement to escalate care. The efficacy of high-flow oxygen therapy in children aged 1 to 4 years with acute hypoxemic respiratory failure without bronchiolitis is unknown. Objective: To determine the effect of early high-flow oxygen therapy vs standard oxygen therapy in children with acute hypoxemic respiratory failure. Design, Setting, and Participants: A multicenter, randomized clinical trial was conducted at 14 metropolitan and tertiary hospitals in Australia and New Zealand, including 1567 children aged 1 to 4 years (randomized between December 18, 2017, and March 18, 2020) requiring hospital admission for acute hypoxemic respiratory failure. The last participant follow-up was completed on March 22, 2020. Interventions: Enrolled children were randomly allocated 1:1 to high-flow oxygen therapy (n = 753) or standard oxygen therapy (n = 764). The type of oxygen therapy could not be masked, but the investigators remained blinded until the outcome data were locked. Main Outcomes and Measures: The primary outcome was length of hospital stay with the hypothesis that high-flow oxygen therapy reduces length of stay. There were 9 secondary outcomes, including length of oxygen therapy and admission to the intensive care unit. Children were analyzed according to their randomization group. Results: Of the 1567 children who were randomized, 1517 (97%) were included in the primary analysis (median age, 1.9 years [IQR, 1.4-3.0 years]; 732 [46.7%] were female) and all children completed the trial. The length of hospital stay was significantly longer in the high-flow oxygen group with a median of 1.77 days (IQR, 1.03-2.80 days) vs 1.50 days (IQR, 0.85-2.44 days) in the standard oxygen group (adjusted hazard ratio, 0.83 [95% CI, 0.75-0.92]; P <.001). Of the 9 prespecified secondary outcomes, 4 showed no significant difference. The median length of oxygen therapy was 1.07 days (IQR, 0.50-2.06 days) in the high-flow oxygen group vs 0.75 days (IQR, 0.35-1.61 days) in the standard oxygen therapy group (adjusted hazard ratio, 0.78 [95% CI, 0.70-0.86]). In the high-flow oxygen group, there were 94 admissions (12.5%) to the intensive care unit compared with 53 admissions (6.9%) in the standard oxygen group (adjusted odds ratio, 1.93 [95% CI, 1.35-2.75]). There was only 1 death and it occurred in the high-flow oxygen group. Conclusions and Relevance: Nasal high-flow oxygen used as the initial primary therapy in children aged 1 to 4 years with acute hypoxemic respiratory failure did not significantly reduce the length of hospital stay compared with standard oxygen therapy. Trial Registration: anzctr.org.au Identifier: ACTRN12618000210279 This randomized clinical trial compares the effect of early high-flow oxygen therapy vs standard oxygen therapy on length of hospital stay in children with acute hypoxemic respiratory failure.
- Subjects
NEW Zealand; AUSTRALIA; NASAL cannula; NONINVASIVE ventilation; OXYGEN therapy; LENGTH of stay in hospitals; TREATMENT duration; HOSPITAL care of children; CLINICAL trials
- Publication
JAMA: Journal of the American Medical Association, 2023, Vol 329, Issue 3, p224
- ISSN
0098-7484
- Publication type
Article
- DOI
10.1001/jama.2022.21805