Donna Franklin1,2,3, Deborah Shellshear4,3,5, Franz E Babl3,6,7,8, Rikki Hendrickson4,5, Amanda Williams3,6,7,8, Kristen Gibbons2,9, Kate McEnery2, Melanie Kennedy4,2, Trang Mt Pham2, Jason Acworth4,3,5, David Levitt4,10, Ed Oakley3,6,7,8, Andreas Schibler4,2,3. 1. Gold Coast University Hospital, Emergency Department Collaborative Research Group, Southport, Australia. 2. The University of Queensland, Paediatric Critical Care Research Group, Child Health Research Centre, School of Medicine, South Brisbane, Australia. 3. PREDICT (Paediatric Research in Emergency Departments International Collaborative), Parkville, Victoria, Australia. 4. Queensland Children's Hospital, Brisbane, Australia. 5. Paediatric Emergency Department, Children's Health Queensland and Health Services, Brisbane, Queensland, Australia. 6. Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia. 7. Emergency Department, Royal Children's Hospital, Melbourne, Victoria, Australia. 8. Emergency Research, Murdoch Children's Research Institute, Melbourne, Victoria, Australia. 9. Mater Research Institute, The University of Queensland, Brisbane, Queensland, Australia. 10. Department of Paediatrics, Children's Health Queensland and Health Services, South Brisbane, Queensland, Australia.
Abstract
AIMS: High-flow is increasingly used in children with acute hypoxaemic respiratory failure (AHRF), despite limited evidence. The primary feasibility endpoint for this pilot-study was the proportion of treatment failure, secondary outcomes being intensive care unit (ICU) admissions and proportion of patients requiring escalation of care. We measured duration of hospital stay, duration of oxygen therapy and rates of ICU admission. METHODS: An open-labelled randomised controlled trial feasibility design was used in two tertiary children's hospitals in the emergency department and general wards. Children aged 0-16 years with AHRF were randomised (1:1) to either high-flow or standard-oxygen. Children on standard-oxygen received rescue high-flow in general wards if failure criteria were met. RESULTS: Of 563 randomised, 283 received high-flow and 280 standard-oxygen with no adverse events. The proportion of children who failed treatment and receiving escalation of care was 11.7% (32/283 children) on high-flow and 18.1% (50/280 infants) on standard-oxygen (odds ratio 0.68, 95% confidence interval 0.38-1.00). In children with obstructive airway disease, 9.7% on high-flow and 17.4% on standard-oxygen required escalation (risk-difference -7.7% percentage points; 95% confidence interval -14.3, -1.1); in children with non-obstructive disease no difference was observed. Neither difference in ICU admissions nor any difference in length of hospital stay was observed. Sixty percent of children who failed standard-oxygen responded to rescue high-flow. CONCLUSION: High-flow outside ICU appears to be feasible in children with AHRF and the required proportion of escalation was lower compared to standard-oxygen. The trial design can be applied in a future large randomised controlled trial.
RCT Entities:
AIMS: High-flow is increasingly used in children with acute hypoxaemic respiratory failure (AHRF), despite limited evidence. The primary feasibility endpoint for this pilot-study was the proportion of treatment failure, secondary outcomes being intensive care unit (ICU) admissions and proportion of patients requiring escalation of care. We measured duration of hospital stay, duration of oxygen therapy and rates of ICU admission. METHODS: An open-labelled randomised controlled trial feasibility design was used in two tertiary children's hospitals in the emergency department and general wards. Children aged 0-16 years with AHRF were randomised (1:1) to either high-flow or standard-oxygen. Children on standard-oxygen received rescue high-flow in general wards if failure criteria were met. RESULTS: Of 563 randomised, 283 received high-flow and 280 standard-oxygen with no adverse events. The proportion of children who failed treatment and receiving escalation of care was 11.7% (32/283 children) on high-flow and 18.1% (50/280 infants) on standard-oxygen (odds ratio 0.68, 95% confidence interval 0.38-1.00). In children with obstructive airway disease, 9.7% on high-flow and 17.4% on standard-oxygen required escalation (risk-difference -7.7% percentage points; 95% confidence interval -14.3, -1.1); in children with non-obstructive disease no difference was observed. Neither difference in ICU admissions nor any difference in length of hospital stay was observed. Sixty percent of children who failed standard-oxygen responded to rescue high-flow. CONCLUSION: High-flow outside ICU appears to be feasible in children with AHRF and the required proportion of escalation was lower compared to standard-oxygen. The trial design can be applied in a future large randomised controlled trial.
Authors: Simon Craig; Colin V E Powell; Gillian M Nixon; Ed Oakley; Jason Hort; David S Armstrong; Sarath Ranganathan; Amit Kochar; Catherine Wilson; Shane George; Natalie Phillips; Jeremy Furyk; Ben Lawton; Meredith L Borland; Sharon O'Brien; Jocelyn Neutze; Anna Lithgow; Clare Mitchell; Nick Watkins; Domhnall Brannigan; Joanna Wood; Charmaine Gray; Stephen Hearps; Emma Ramage; Amanda Williams; Jamie Lew; Leonie Jones; Andis Graudins; Stuart Dalziel; Franz E Babl Journal: BMJ Open Respir Res Date: 2022-03