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Published on: May 11, 2015
High flow in children with respiratory failure: A randomised controlled pilot trial - A paediatric acute respiratory
Donna Franklin1,2,3, Deborah Shellshear4,3,5, Franz E Babl3,6,7,8
1Gold Coast University Hospital, Emergency Department Collaborative Research Group, Southport, Australia.
Insights
High-flow oxygen therapy is feasible for pediatric acute hypoxemic respiratory failure (AHRF), showing lower escalation rates than standard oxygen. This pilot study supports its use outside the intensive care unit (ICU).
Area of Science:
- Pediatric critical care medicine
- Respiratory medicine
- Clinical trial design
Background:
- High-flow oxygen therapy is increasingly utilized for pediatric acute hypoxemic respiratory failure (AHRF).
- Evidence supporting its efficacy and feasibility in this population remains limited.
- Current treatment guidelines often lack specific recommendations for high-flow use in children.
Purpose of the Study:
- To assess the feasibility of high-flow oxygen therapy in children with AHRF outside the intensive care unit (ICU).
- To determine the primary endpoint of treatment failure proportion.
- To evaluate secondary outcomes including ICU admissions and escalation of care.
Main Methods:
- An open-label, randomized controlled trial feasibility design was employed.
- Children aged 0-16 years with AHRF were randomized (1:1) to receive either high-flow or standard oxygen.
- Rescue high-flow was administered to standard oxygen patients meeting failure criteria.
Main Results:
- No adverse events were reported in 563 randomized children (283 high-flow, 280 standard-oxygen).
- Treatment escalation occurred in 11.7% of high-flow recipients versus 18.1% of standard-oxygen recipients (OR 0.68).
- In obstructive airway disease, high-flow showed a significant reduction in escalation rates (RD -7.7%). No difference was observed in non-obstructive disease. ICU admissions and hospital stay duration did not differ significantly.
Conclusions:
- High-flow oxygen therapy outside the ICU is feasible for pediatric AHRF.
- The proportion of patients requiring escalation of care was lower with high-flow compared to standard oxygen.
- The study design is suitable for a future large randomized controlled trial.
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.
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