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Safe, effective and cost-effective oxygen saturation targets for children and adolescents with respiratory distress:
Sam Louman1,2, Karlijn J van Stralen3, Gerard Koppelman4,5
1Spaarne Gasthuis Academy, Hoofddorp, The Netherlands slouman@spaarnegasthuis.nl.
Insights
A lower oxygen saturation threshold of 88% may safely reduce hospital stays for children with respiratory distress. This study compares 88% versus 92% thresholds to evaluate effectiveness and cost-efficiency.
Area of Science:
- Pediatrics
- Respiratory Medicine
- Clinical Trials
Background:
- Current oxygen saturation (SpO2) thresholds (90%-94%) for children with respiratory distress may lead to prolonged oxygen use and hospital stays.
- A lower SpO2 threshold of 88% is proposed to balance oxygen administration and prevent hypoxia.
- Effectiveness and safety of lower SpO2 thresholds in pediatric respiratory distress are largely unknown.
Purpose of the Study:
- To test if a lower SpO2 threshold of 88% safely reduces hospital stay in children with respiratory distress compared to a 92% threshold.
- To assess the cost-effectiveness of the lower SpO2 threshold.
Main Methods:
- Multicenter, open-label, randomized controlled trial involving 560 children (6 weeks to 12 years) with respiratory infections.
- Two arms: Intervention (SpO2 <88% for oxygen) and Control (SpO2 <92% for oxygen).
- Primary outcome: time to meeting discharge criteria. Secondary outcomes include length of stay, safety, quality of life, and costs.
Main Results:
- Primary outcome data not yet available as the study is ongoing.
- Secondary outcome data collection includes length of stay, safety metrics, quality of life, and societal costs.
- Follow-up via digital questionnaires up to 90 days post-discharge.
Conclusions:
- The study aims to provide evidence on the optimal SpO2 threshold for oxygen therapy in pediatric respiratory distress.
- Findings will inform clinical practice guidelines, potentially reducing healthcare costs and improving patient/family experience.
- Results will be disseminated through publications and conferences.
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.
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