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Table 2 Planned figures and tables

From: A multicenter cluster randomized, stepped wedge implementation trial for targeted normoxia in critically ill trauma patients: study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen (SAVE-O2) trial

Proposed tables

(stratified by treatment condition pre- vs post-intervention)

Table 1: Patient characteristics (stratified by treatment

Table 2: Primary Outcome – SOFD

- SOFD (Mean, SD) among survivors

- In-hospital mortality (n, %)

- Alive with 0 SOFD (n, %)

- Alive with 28 SOFD (n, %)

Table 3: Secondary clinical outcomes

- HFD90

- In-hospital mortality to day 90

- VFD28

- Time to room air

- GOS

- Discharge disposition

Table 4: Secondary oxygenation outcome

- Amount of supplemental oxygen administered

- Duration of time on normoxia protocol target

- Proportion receiving high levels of supplemental oxygen while in ICU

- Duration of time receiving high levels of supplemental oxygen

- Duration of time receiving no supplemental oxygen

- Incidence of hypoxic and hyperoxic events

- Duration of hypoxic and hyperoxic evens

Proposed figures

Figure 1: CONSORT diagram

Figure 2: Histogram of SOFD stratified by treatment conditions

Figure 3: Time to mortality stratified by treatment condition (Kaplan-Meier Curve)

Supplemental Tables/Figures

Supplementary Table 1: Patient characteristics by site

Supplementary Table 2: Primary Outcome – SOFD by site

Supplementary Table 3: Secondary Outcomes by site

Supplementary Table 4: Subgroup analysis by trauma subgroup

Supplementary Table 5: Subgroup analysis by Injury Severity Score

  1. Abbreviations: GOS Glasgow Outcome Score, HFD90 hospital-free days to day 28, ICU intensive care unit, SD standard deviation, SOFD supplemental oxygen-free days, VFD28 ventilator-free days to day 28