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Table 4 Per-protocol analysis: primary and secondary outcomes

From: A randomized clinical trial for the timing of tracheotomy in critically ill patients: factors precluding inclusion in a single center study

 

Early n = 101

Late n = 104

P-value

28-day mortality

20 (20%; 13 to 29)

30 (29%; 20 to 38)

0.1317

90-day mortality

30 (30%; 21 to 40)

44 (42%; 33 to 52)

0.0603

Hospital mortality

31 (31%; 22 to 41)

45 (43%; 34 to 53)

0.0623

Days free of mechanical ventilation, 28-day

8 (0, 22)

4 (0, 22)

0.0003

Days free of mechanical ventilation, 90-day

70 (24 to 84)

66 (0 to 84)

0.0002

Duration of sedation

11 (2 to 66)

16.5 (5 to 63)

0.0006

ICU length of stay

24 (6 to 84)

29 (6 to 174)

0.0276

Other characteristics related to mechanical ventilation and tracheotomy

   

Weaning protocol applied in intubated patients

16 (16%; 9 to 24)

27 (26%; 18 to 36)

0.0752

Failed extubation (reintubated)

13 (13%; 6 to 20)

11 (11%; 5 to 18)

0.6095

Days of intubation in tracheotomized patients

7 (5 to 7)

14 (14 to 22)

0.0000

Days of intubation in successfully extubated patients

0

14 (11 to 17)

 

Patients sedated, n, %

95 (94%; 87 to 98)

102 (98%; 93 to 99)

0.1375

Deep sedation with neuroblocker drugs

19 (19%; 12 to 28)

27 (26%; 18 to 36)

0.2199

Maximum positive end-expiratory pressure

7 (2 to 16)

7 (3 to 15)

0.8966

Ventilator-associated pneumonia

11 (11%; 6 to 19)

12 (12%; 6 to 19)

0.8833

Early complications of tracheotomy

2 (2%;0.3-7)

5 (6.6%; 1.5-11)

0.2417

  1. Results of the quantitative variables are expressed in medians and ranges. Qualitative variables are expressed in percentages and their 95% CI.