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Table 2 Study outcomes

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 value

Percentage of shifts at target RASS = 0, median [IQR]

82.9 [61.3–100]

93.3 [70.8–100]

< 0.01

Percentage of shifts at observed RASS = 0/− 1, median [IQR]

57.9 [33.3–77.8]

60.1 [33.3–83.7]

0.53

Main outcome

 Percentage of shifts at RASS observed = target ±1, median [IQR]

94.4 [77.8–100]

89.8 [74.1–100]

0.20

Secondary outcomes

Percentage of adequate sedation, as judged by nurses, median [IQR]

92.4 [80.9–100]

89.7 [76.2–100]

0.11

Percentage of shifts with protocol violation, median [IQR]

0 [0–0]

0 [0–24.1]

< 0.01

Patients with protocol violation, n (%)

7 (4.2)

81 (46.6)

< 0.01

Coma-free days

27 [19–28]

27 [18–28]

0.80

Delirium-free days

27 [19–28]

27 [15–28]

0.40

Coma and delirium-free days

25 [11–28]

25 [10–28]

0.61

Ventilator-free days

21 [3–27]

22 [2–26]

0.89

Length of ICU stay

10 [6–18]

10 [6–18]

0.75

Mortality

 In ICU, n (%)

41 (24.8)

45 (25.9)

0.90

 In hospital, n (%)

54 (32.7)

62 (35.6)

0.65

 One year, n (%)

68 (43.9)

71 (43.0)

0.82

Daily cost for planned sedatives, €/ventday

1.64 [0.15–4.78]

0.38 [0.22–0.60]

< 0.01

Daily cost for unplanned sedatives, €/ventday

0 [0–0]

0.16 [0–2.15]

< 0.01

Daily cost for all neuroactive drugs, €/ventday

4.15 [1.20–20.19]

2.39 [0.75–9.78]

0.01

Self-removal of ET tube, n (%)

4 (2.4)

14 (8.1)

0.03

Need to replace ET tube, n (%)

3 (1.8)

10 (5.7)

0.09

Self-removal of other invasive tools, n (%)

21 (12.7)

29 (16.7)

0.36

Unscheduled neurological tests, n (%)

30 (18.2)

33 (19.0)

0.89

  1. Abbreviations: IV intravenous, EN enteral, RASS Richmond Agitation Sedation Scale, ICU Intensive Care Unit, ventday day with mechanical ventilation, ET endotracheal