Donna Franklin1, Franz E Babl1, Luregn J Schlapbach1, Ed Oakley1, Simon Craig1, Jocelyn Neutze1, Jeremy Furyk1, John F Fraser1, Mark Jones1, Jennifer A Whitty1, Stuart R Dalziel1, Andreas Schibler1. 1. From 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.).
Abstract
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 eitherhigh-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 .).
RCT Entities:
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 .).
Authors: Luregn J Schlapbach; Ben Gelbart; Marino Festa; Hari Krishnan Kanthimathinathan; M J Peters Journal: Intensive Care Med Date: 2019-03-06 Impact factor: 17.440
Authors: Regina Grigolli Cesar; Bibiane Ramos Pinheiro Bispo; Priscilla Helena Costa Alves Felix; Maria Carolina Caparica Modolo; Andreia Aparecida Freitas Souza; Nelson K Horigoshi; Alexandre T Rotta Journal: J Pediatr Intensive Care Date: 2020-04-17