Safe, Effective and Cost-effective Oxygen Saturation Targets for Children and Adolescents with Respiratory Distress: Protocol for a Randomised Controlled Trial (OxyKids Study)

Introduction: Little is known about the effectiveness and safety of oxygen saturation (SpO2) thresholds in children admitted with respiratory distress. The current 90%-94% threshold could lead to prolonged administration of supplemental oxygen, increased duration of hospital admissions, distress for children and families, and healthcare costs. To balance reducing unnecessary oxygen administration and preventing hypoxia, a lower SpO2 threshold of 88% for oxygen supplementation in children has been suggested. This trial aims to test the hypothesis that a lower SpO2 threshold of 88% safely reduces the length of hospital stay in children admitted with respiratory distress when compared with a 92% SpO2 threshold and to assess its cost-effectiveness.

Methods And Analysis: This is a multicentre, open-label, randomised controlled trial with two parallel arms. A total of 560 children aged 6 weeks to 12 years admitted with a diagnosis of bronchiolitis, viral wheeze or lower respiratory tract infection will be recruited and equally randomised into an intervention or usual care arm. Intervention arm patients will receive supplemental oxygen if SpO2 falls below 88% or above 88% if deemed necessary by clinical staff. Control arm patients will receive supplemental oxygen if SpO2 falls below 92% or above 92% if deemed necessary by staff. The primary outcome is the time from admission to the time when all prespecified discharge criteria are met. Secondary outcomes are length of stay, safety (time to recovery, readmissions and paediatric intensive care admissions), quality of life, parental anxiety and societal costs. Patients are followed up by digital questionnaires up to 90 days postdischarge.

Ethics And Dissemination: This study has received approval from the research ethics committee (REC) of Leiden, Den Haag and Delft (EU CT number 2023-504817-56). Written informed consent will be obtained from parents or guardians. Parents of patients and patient representatives are involved in all stages of the study, from design to results, interpretation and dissemination. The results of this trial will be disseminated via lay publications, peer-reviewed scientific journals and academic conferences.

Trial Registration Number: NCT06016244.