Statistical analysis
Over-estimation, trauma
REGRESSION
An intention-to-treat analysis was performed as the principal analysis. The primary outcome was compared between groups by using a logistic regression model adjusted on randomization stratification factors (center and PaOSample size calculation was based on an estimated rate of the primary endpoint of 12% in the experimental group and 25% in the control group, in accordance with previous studies in high-risk trauma patients with TTS score ≥ 8 [However, the intubation rate was much lower than expected. Over-estimation of incidence of the primary outcome made the study likely underpowered to detect any inter-group difference, even if the computed sample size was reached. Consequently, study enrollment was stopped for futility after a 2-year study period and randomization of 141 patients.Statistical analyses were performed by the Clinical Epidemiology Unit (USMR, Bordeaux University Hospital) with the R software (version 4.2.1).