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Table 2 Comparison outcomes during the intervention period and at 7 days post-randomisation for the entire study cohort

From: A randomized controlled proof-of-concept trial of early sedation management using Responsiveness Index monitoring in mechanically ventilated critically ill patients

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
  1. The intervention period was defined as being from the start of monitoring to 48 hours post ICU admission. RI Responsiveness Index, RASS Richmond agitation-sedation scale