Comparing restrictive versus liberal oxygen strategies for trauma patients: The TRAUMOX2 trial—Statistical analysis plan
Study context
- Population
- Adult trauma patientsplanned sample size
- Participants
- 1,420 patients
- Planned comparison
- Restrictive vs liberal oxygen strategy for 8 h
- Primary endpoint
- Composite of:
- 30-day mortality
- Major respiratory complications (pneumonia and/or ARDS)
- Follow-up
- 30 days
Methodological detailsvariable block sizes, stratified, multicentre, modified intention-to-treat and per-protocol analyses, prespecified interim analyses at 25% and 50%, Planned 1420 patients to detect a 33% RR reduction of the primary outcome with 80% power at 5% significance, Logistic regression, OR with 95% CI adjusted for stratification variables (centre, tracheal intubation at inclusion)
- Variable block sizes
- Stratified
- Multicentre
- Modified intention-to-treat and per-protocol analyses
- Prespecified interim analyses at 25% and 50%
- Planned 1420 patients to detect a 33% RR reduction of the primary outcome with 80% power at 5% significance
- Logistic regression, OR with 95% CI adjusted for stratification variables (centre, tracheal intubation at inclusion)
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Comparing restrictive versus liberal oxygen strategies for trauma patients: The TRAUMOX2 trial—Statistical analysis plan. Acta Anaesthesiol Scand. Published 28 March 2023. doi:10.
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