Table 2 Comparison outcomes during the intervention period and at 7 days post-randomisation for the entire study cohort
Outcome | Intervention (n = 36) | Control (n = 38) | P value |
|---|---|---|---|
Outcomes during 48-hour intervention period | |||
Proportion of hours during the intervention period with RI value <20, median | 16 | 33 | 0.08 |
(1st, 3rd quartile; min– max) | (8, 30; 1–87) | (10, 54; 0–86) | |
Time, hours from start of monitoring to first RI value >20, median | 0.1 | 0.3 | 0.43 |
(1st, 3rd quartile; min– max) | (0.0, 2.2, 0.0–7.8) | (0.0, 3.1, 0.0–48) | |
Proportion of RASS scores of −4 or −5 during the intervention period, median | 12 | 17 | 0.70 |
(1st, 3rd quartile; min– max) | (0, 35; 0–94) | (3, 36; 0–100) | |
Time, hours from start of monitoring to first RASS score >−4, median | 2 | 3 | 0.68 |
(1st, 3rd quartile; min– max) | (0, 8, 0–43) | (0, 8, 0–48) | |
Total propofol dose, mg, during the intervention period, median | 1,365 | 1,730 | 0.64 |
(1st, 3rd quartile; min– max) | (380, 2,790; 50–8,710) 1730 | (620, 3,260; 0–8,630) | |
Total alfentanil dose, mg, during the intervention period, median | 23.4 | 25.2 | 0.68 |
(1st, 3rd quartile; min– max) | (9.0, 36.4; 0.0–51.5) | (8.6, 36.0; 0.3–87.0) | |
Number (%) of patients undergoing sedation hold during the intervention period | 30/36 (83) | 33/38 (87) | 0.751 |
Number (%) of patients extubated during the intervention period | 17/36 (47.2 %) | 17/38 (44.7 %) | 1.00 |
Proportion of hours in intervention period during which patient extubated, median | 4 | 0 | 0.49 |
(1st, 3rd quartile; min– max) | (0–62; 0–92) | (0, 44; 0–97) | |
Number (%) of patients with any predefined adverse events during intervention period | 7/36 (19.4 %) | 5/38 (13.1 %) | 0.54 |
Unplanned extubation, number | 0 | 1 | |
Unplanned removal of vascular catheter, number | 0 | 0 | |
Unplanned removal of nasogastric or other enteral tube, number | 1 | 0 | |
Unplanned removal of other drain or device, number | |||
Episode of myocardial ischaemia, number | 0 | 0 | |
Myocardial infarction, number | 0 | 0 | |
Episode of agitation requiring bolus treatment with haloperidol or sedative drug (rescue medication), number | 0 | 0 | |
6 | 4 | ||
Outcomes at 7 days post-randomisation | |||
Time from start of monitoring to first extubation, hours, median | 42.4 | 54.8 | 0.52 |
(1st, 3rd quartile; min– max) | (14.7, 168.0; 2.0–168.0) | (22.8, 168.0; 1.78–168.0) | |
Deaths, number (%) | 1/36 (2.8 %) | 3/38 (7.9 %) | 0.62 |
Discharged from ICU, number (%) | 20/36 (55.6 %) | 18/38 (47.4 %) | 0.50 |
Still in ICU, number (%) | 15/36 (41.7 %) | 15/38 (41.7) | 1.00 |
Transferred to another ICU, number (%) | 0/36 (0 %) | 2/38 (2 %) | 0.49 |