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Table 1 Demographic and baseline characteristics at randomization

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

  Control (n = 590) Oversedation prevention (n = 584)
Age (years), mean (SD) 67 (14) 66 (13)
Female gender, n (%) 200 (33.9) 202 (34.6)
BMI (kilograms divided by height in metres squared), mean (SD) 26.7 (6.6) 27.4 (7.1)
Chronic alcohol use, n (%) 115 (19.5) 126 (21.6)
Chronic psychotropic medication use, n (%) 177 (30.0) 166 (28.4)
 Benzodiazepine and related medications 110 (18.6) 109 (18.7)
 Neuroleptics 22 (3.7) 33 (5.7)
 Antidepressants 72 (12.2) 70 (12.0)
 Opioid medication 42 (7.1) 35 (6.0)
Tobacco use, n (%) 156 (26.5) 169 (28.9)
Liver cirrhosis with ascites or oesophageal varices, n (%) 34 (5.8) 37 (6.3)
Chronic renal replacement therapy, n (%) 9 (1.5) 10 (1.7)
Chronic respiratory insufficiency with home oxygen therapy, n (%) 42 (7.1) 51 (8.7)
NYHA class IV chronic heart failure, n (%) 16 (2.7) 23 (3.9)
Barthel score before admission, median (Q1–Q3) 100 (100–100) 100 (95–100)
Knauss chronic health status before admission, n (%)
 Normal health status 155 (26.3) 152 (26.0)
 Moderate activity limitation 285 (48.3) 267 (45.7)
 Severe activity limitation due to chronic disease 139 (23.6) 157 (26.9)
 Bedridden patient 11 (1.9) 8 (1.4)
MacCabe class before admission, n (%)
 No fatal disease 363 (61.5) 348 (59.6)
 Ultimately fatal disease 181 (30.7) 197 (33.7)
 Rapidly fatal disease 46 (7.8) 39 (6.7)
At home without assistance before current hospital admission, n (%) 373 (63.2) 367 (62.8)
ICU admission SAPS II score (first 24 h), mean (SD) 54.4 (18.6) 53.6 (17.8)
ICU admission SOFA score (first 24 h), median (Q1–Q3) 9 (7–12) 9 (7–12)
Medical admission, n (%) 520 (88.1) 530 (90.8)
Norepinephrine at randomization, n (%) 312 (53.0) 318 (54.5)
Midazolam at randomization (n1 = 493, n2 = 496), n (%) 412 (83.6) 421 (84.9)
Propofol at randomization (n1 = 493, n2 = 496), n (%) 74 (15.0) 69 (13.9)
Severe sepsis, n (%) 50 (8.5) 57 (9.8)
Septic shock, n (%) 339 (57.5) 323 (55.3)
ARDS, n (%) 186 (31.5) 187 (32.1)
ICU primary diagnosis
 Pulmonary infection, n (%) 246 (41.7) 239 (40.9)
 Abdominal infection, n (%) 49 (8.3) 54 (9.3)
 Other Infection, n (%) 41 (6.9) 57 (9.8)
 Cardiac failure or cardiogenic pulmonary oedema, n (%) 56 (9.5) 53 (9.1)
 COPD exacerbation or acute asthma, n (%) 51 (8.6) 51 (8.7)
 Acute pancreatitis, n (%) 9 (1.5) 13 (2.2)
 Drug intoxication, n (%) 12 (2.0) 9 (1.5)
 Metabolic disorder, n (%) 18 (3.1) 7 (1.2)
 Trauma, n (%) 7 (1.2) 7 (1.2)
 Acute stroke, n (%) 5 (0.8) 2 (0.3)
 Miscellaneous, n (%) 96 (16.3) 92 (15.8)
Sedation level on the RASS scale at randomizationa
 Very agitated, n (%) 1 (0.4) 3 (1.1)
 Agitated, n (%) 4 (1.5) 1 (0.4)
 Restless, n (%) 3 (1.1) 5 (1.9)
 Alert and calm, n (%) 12 (4.5) 12 (4.6)
 Drowsy, n (%) 12 (4.5) 12 (4.6)
 Light sedation, n (%) 21 (7.9) 15 (5.7)
 Moderate sedation, n (%) 30 (11.3) 23 (8.8)
 Deep sedation, n (%) 63 (23.8) 66 (25.2)
 Unarousable, n (%) 119 (44.9) 125 (47.7)
  1. SD, standard deviation; BMI, body mass index; NYHA, New York Heart Association; Q1–Q3, 1st and 3rd quartiles; SAPS, Simplified Acute Physiology Score, SOFA, Sequential Organ Failure Assessment; ICU, intensive care unit, COPD, chronic obstructive pulmonary disease; ARDS, acute respiratory distress syndrome
  2. aSedation was measured using the RASS scale in 268 patients in the control group and 267 patients in the oversedation prevention group. The exact level on the RASS scale was not available for 3 patients in the control group and 5 patients in the oversedation prevention group.