Nasal High Flow in Children with Acute Hypoxemic Respiratory Failure. A Paediatric Acute Respiratory Intervention Study (Paris)
52 Pages Posted: 23 Jun 2019More...
Background: High-flow oxygen-therapy is increasingly used in children with acute hypoxic respiratory failure (AHRF), despite limited high-quality evidence of efficacy outside intensive care units.
Methods: An open labelled RCT feasibility design was used in emergency departments and general wards of two tertiary children's hospitals. Over a period of 1-year, children aged 0-16 years with AHRF were randomised (1:1) to either high-flow or standard-oxygen. Children on the standard-oxygen could receive rescue high-flow in the general wards if their conditions met treatment failure criteria. The primary efficiency-endpoints were feasibility, recruitment rates and safety followed by the efficacy-endpoints measuring the proportion escalation of care. We measured the duration of hospital stay, duration of oxygen therapy and rates of ICU admission.
Findings: Of 563 randomised, 283 received high-flow and 280 standard-oxygen with no adverse events. The proportion of children receiving escalation of care was 11.7% (32/283 children) on the high-flow and 18.1% (50/280 infants) on standard-oxygen (risk difference -6.4 percentage points; 95% CI -12.4%, -0.5%; p=0.04). 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% CI -14.3%, -1.1%; p=0.03), whereas in children with non-obstructive disease no difference was observed. No difference in length of hospital stay was observed. 40% of children who failed standard-oxygen responded to rescue high-flow.
Interpretation: High-flow outside ICU appears to be safe 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 RCT.
Trial Registration: The study protocol was registered with the Australian and New Zealand Clinical Trials Registry. (ACTRN12615001305516).
Funding Statement: The study was supported by a grant provided by Thrasher Research Fund and a project grant provided by the National Health and Medical Research Council.
The high-flow equipment and consumables for both trial sites were donated by Fisher & Paykel Healthcare, which had no involvement in the design and conduct of the trial, the analysis of the data, or in the preparation of the manuscript.
Declaration of Interests: DF and AS report financial support for travel and accommodation provided by Fisher&Paykel Healthcare, Auckland, New Zealand
Ethics Approval Statement: The study was approved by Children’s Health Queensland Human Research Ethics Committee (HREC/15/QRCH/159) and the authors used a consent to continue process.
Keywords: Paediatrics, Oxygen saturation, Respiratory Distress, Reactive Airways Disease, Acute respiratory failure
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