Background: Oxygen saturation monitoring for children receiving respiratory support is standard worldwide. No ran- domised clinical trials have compared peripheral oxygen saturation (SpO ) targets for critically ill children. The harm of interventions to raise SpO to > 94% may exceed their benefits. Methods: We undertook an open, parallel-group randomised trial of children > 38 weeks completed gestation and < 16 years of age receiving invasive or non-invasive respiratory support and supplemental oxygen who were admitted urgently to one of three paediatric intensive care units. A ‘research without prior consent’ approach was employed. Children were randomly assigned to a liberal oxygenation group (SpO targets > 94%) or a conservative oxygenation group (SpO = 88–92% inclusive). Outcomes were measures of feasibility: recruitment rate, protocol adherence and acceptability, between-group separation of SpO and safety. The Oxy-PICU trial was registered before recruitment: ClinicalTrials.gov identifier NCT03040570. Results: A total of 159 children met the inclusion criteria, of whom 119 (75%) were randomised between April and July 2017, representing a rate of 10 patients per month per site. The mean time to randomisation from first contact with an intensive care team was 1.9 (SD 2.2) h. Consent to continue in the study was obtained
Intensive Care Medicine – Springer Journals
Published: Jun 4, 2018
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