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Table 3 Neurological observations

From: Enteral versus intravenous approach for the sedation of critically ill patients: a randomized and controlled trial

  Group IV
N = 165
Group EN
N = 174
P values
Maximum number of theoretical observations 5529 6663 group time group*time
Pain (VNR ≥ 3 or BPS ≥ 6), n (%) 663 (12.0) 734 (11.0) 0.73 0.29 0.12
Anxiety (VNR > 0), n (%) 511 (33.7) 574 (32.4) 0.99 0.17 0.14
Physical restraint use > 1 h, n (%) 694 (18.0) 785 (16.2) 0.62 < 0.01 0.42
Sleep time > 2 h observed by nurses, n (%) 571 (86.1) 649 (86.3) 0.81 < 0.01 0.07
Agitation hours > 1, n (%) 311 (20.3) 304 (17.6) 0.81 0.46 0.51
Coma- and delirium-free shift, n (%) 3004 (64.5) 3552 (64.8) 0.20 < 0.01 < 0.01
Delirium (CAM-ICU ), n (%) 644 (13.8) 998 (18.2) 0.72 0.02 0.98
Coma (RASS = − 4 or − 5), n (%) 1009 (21.7) 933 (17.0) 0.11 < 0.01 < 0.01
Sedation adequacy, n (%)
 Insufficient 483 (8.9) 682 (10.4) 0.65 0.28 0.62
 Adequate 4664 (85.4) 5324 (81.1)
 Excessive 313 (5.7) 555 (8.5)
  1. Variables are presented as absolute number (percentage of gathered observations). Comparisons made by multilevel mixed-effects Poisson regressions to simultaneously analyze the net effect of group assignment; the effect of time spent in ICU; the cumulative sedative effect, calculated by multiplying the group (enteral = 1, intravenous = 0) and the number of ICU staff shifts from group assignment, to highlight the adjunctive effects of the repeated sedative administration
  2. Abbreviations: IV intravenous, EN enteral, VNR verbal numeric rating, BPS Behavioral Pain Scale, RASS Richmond Agitation Sedation Scale, CAM-ICU Confusion Assessment Method for Intensive Care Unit