Table 2.
Adjusted primary and secondary trial outcomes
| Control, n (%) | Intervention, n (%) | Estimatea, (95% CI) | P value | |
|---|---|---|---|---|
| ICU mortality group, N | 1555 | 1691 | ||
| ICU mortalityb | 330 (21.2) | 399 (23.5) | 1.13 (0.82 to 1.54) | 0.46 |
| IVAC group, N | 947 | 987 | ||
| IVACsb | 24 (2.5) | 48 (4.8) | 1.06 (0.44 to 2.57) | 0.90 |
| BOAS group, N | 154 | 182 | ||
| BOAS mean score (SD)c | 11.24 (3.2) | 10.47 (3.2) | − 0.96 (1.75 to − 0.17) | 0.02 |
| BOAS categorized | ||||
| No dysfunction (5) | 8 (5.0) | 6 (3.1) | ||
| Mild dysfunction (6–10) | 50 (32.5) | 86 (47.2) | ||
| Moderate dysfunction (11–15) | 80 (51.9) | 78 (42.8) | ||
| Severe dysfunction (16–20) | 16 (10.4) | 12 (6.5) | ||
| CPOT group, N | 154 | 184 | ||
| CPOT mean score (SD) | 2.32 (1.9) | 2.27 (1.9) | 1.62 (0.91 to 2.91) | 0.10 |
| CPOT categorizedc | ||||
| < 3 | 77 (50) | 106 (57.6) | ||
| ≥ 3 | 77 (50) | 78 (42.3) | ||
| Time to extubation group (survivors), N | 1061 | 994 | ||
| Time to extubation, median, days (IQR)b (SD) | 2 (1–5) | 2 (1–5) | 1.03 (0.85 to 1.23) | 0.79 |
BOAS Beck Oral Health Assessment Score, CPOT Critical-Care Pain Observational Tool, ICU Intensive Care Unit, IQR interquartile range, IVAC infection-related ventilator-associated, SD standard deviation
aOdds ratios for ICU mortality and CPOT dichotomized. Hazard ratio for IVAC and beta coefficient (change in average BOAS score in the intervention group vs control)
bP value based on an analysis that adjusts for age, sex, predicted mortality based on APACHE, operative status as well as secular trends and clustering of patients within ICU
cP values based on analysis adjusting for age, sex, admission category and number of tubes as well as the repeated measures per patient