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Table 2 Outcomes

From: Impact of oversedation prevention in ventilated critically ill patients: a randomized trial—the AWARE study

  Control (n = 590) Oversedation prevention (n = 584) P value Hazard ratio (95% confidence interval)
28-day mortality 198 (33.6) 177 (30.4) 0.24a  
90-day mortality 261 (44.2) 230 (39.4) 0.09a  
1-year mortality 296 (60.0) 267 (56.5) 0.26a  
Mechanical ventilation-free days at day 28 (days), median (Q1–Q3) 14 (0–24) 16 (0-24) 0.36b  
Ventilator-associated pneumonia, n 92 94 0.79c 1.04 (0.78; 1.38)
Mechanical ventilation ≥ 48 h, n (%) 425 (72.0) 418 (71.6) 0.86a  
Non-invasive ventilation after extubation, n (%) 152 (25.8) 177 (30.3) 0.08a  
Duration of non-invasive ventilation after extubation (days), median (Q1–Q3) 2 (1–4) 3 (2–4) 0.05b  
Tracheostomy, n 26 24 0.81c 0.93 (0.54; 1.62)
Delirium, n 232 230 0.99c 1.00 (0.84; 1.19)
Proximal weakness after awakening, n 193 208 0.26c 1.11 (0.92; 1.35)
Patients with intravenous midazolam, n (%) 464 (78.6) 419 (71.8) 0.01a  
Cumulative dosage of midazolam (mg), median (Q1–Q3) 263 (120–660) 218 (72–696) 0.03b  
Patients with intravenous propofol, n (%) 232 (39.3) 214 (36.6) 0.34a  
Cumulative dosage of propofol (mg), median (Q1–Q3) 2785 (645–7140) 1443 (120–4800) < 0.001b  
Patients with intravenous morphinics, n (%) 501 (84.9) 482 (82.5) 0.31a  
Patients with IV sufentanil, n (%) 263 (44.6) 241 (41.3) 0.28a  
Cumulative dosage of sufentanil (µg), median (Q1–Q3) 930 (472–2592) 870 (280-2160) 0.04b  
Patients with IV fentanyl, n (%) 204 (34.6) 206 (35.3) 0.8a  
Cumulative dosage of fentanyl (µg), median (Q1–Q3) 4985 (2400–15,445) 4656 (1340–16,200) 0.29b  
Patients with IV morphine, n (%) 73 (12.4) 91 (15.6) 0.1a  
Cumulative dosage of morphine (mg), median (Q1–Q3) 17.5 (7–55) 20 (6–43) 0.69b  
Patients with IV remifentanil, n (%) 49 (8.3) 45 (7.7) 0.7a  
Cumulative dosage of remifentanil (µg), median (Q1–Q3) 14,400 (6000–28,800) 7200 (3000-19,200) 0.05b  
Self-extubation, n 48 70 0.03c 1.50 (1.04; 2.16)
Ventricular tachycardia or fibrillation, n 18 21 0.61c 1.18 (0.63; 2.11)
Acute coronary syndrome or myocardial infarction, n 7 8 0.77c 1.16 (0.42; 3.18)
Cardiac arrest, n 20 13 0.22c 0.65 (0.33; 1.31)
  1. For comparison of time dependent events analyzed using competing risks models to take into account competing risks as death or extubation (e.g. ventilator associated pneumonia), no percentages are provided
  2. For comparison of variables in post-randomization sub-group (e.g. ICU length of stay in survivors), no P values are provided
  3. CI, confidence interval; Q1–Q3, 1st and 3rd quartiles; MV, mechanical ventilation; VAP, ventilator-associated pneumonia; NIV, non-invasive ventilation; ICU, intensive care unit; LOS, length of stay
  4. aVariables compared using the chi-square test
  5. bVariables compared using the Wilcoxon test
  6. cVariables analyzed using competing risks models to take into account competing risks (as death, extubation, ICU discharge, …). For each of these outcomes, Gray test P value and hazard ratio (95% confidence interval) from competing risks models were presented