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Table 2 Primary and secondary outcomes

From: Spontaneous breathing trial with pressure support on positive end-expiratory pressure and extensive use of non-invasive ventilation versus T-piece in difficult-to-wean patients from mechanical ventilation: a randomized controlled trial

Variables

Extensively-assisted weaning (n = 47)

Standard weaning (n = 47)

 

p-value

 

Median [CI95%]

Median [CI95%]

HR or SHR [95%CI]

 

Primary outcome

    

 Time until successful extubation—Cox model—hrs. §

172 [50–436]

95 [47–232]

0.88 [0.55–1.42]

0.60

Secondary outcomes

    

 Time to successful extubation—Fine and Gray model—hrs. §§

172 [50–436]

95 [47–232]

0.84 [0.53–1.34]

0.47

 Time to death—Fine and Gray model—hrs. §§

488 [346–NR]

633 [321–NR]

1.30 [0.58–2.93]

0.53

 

Median [IQR]

Median [IQR]

Median difference [CI95%]*

p-value

Invasive mechanical ventilation duration [IQR]—hrs. †

129 [25–344]

95 [22–285]

5 [-37–68]

0.73

Mechanical ventilation duration [IQR]—hrs. †

187 [61–355]

122 [46–321]

25 [-42–97]

0.34

Median ventilator-free days at day-28 [IQR]—day †

16 [0–26]

20 [0–26]

0 [− 3–1]

0.59

Median ventilator-free days at day-90 [IQR]—day †

77 [0–88]

82 [0–88]

0 [− 2–1]

0.72

Median ICU length of stay [IQR]—day †

8 [4–18]

9 [4–16]

0 [− 3–3]

0.84

Median hospital length of stay [IQR]—day †

25 [15–47]

26 [12–65]

0 [− 10–8]

0.94

 

No. (%)

No. (%)

Absolute rate difference [CI95%]*

p-value

Rate of successful extubation on the first extubation attempt

22 (47%)

27 (57%)

− 11 [− 30 –11]%

0.41

ICU mortality

14 (30%)

13 (28%)

2 [− 17–21]%

1

Day-28 mortality

15 (32%)

12 (26%)

6 [− 13–23]%

0.65

Day-90 mortality

19 (40%)

15 (32%)

8 [− 11–28]%

0.52

Rate of patients experiencing reintubation among extubated patients

18/41 (44%)

17/44 (39%)

5 [− 16–26]%

0.66

  1. §Cox model including randomization group and strata as explanatory variables
  2. §§Fine and Gray model including randomization group and strata as explanatory variables
  3. CI95% denotes 95% confidence interval; HR, hazard ratio; SHR, subdistribution hazard ratio; NR, not reached; IQR, interquartile range andICU, intensive care unit 
  4. *Median differences with their CI95% were computed with the Hodges Lehmann method and absolute rate difference and CI95% were computed for proportions using bootstrapping
  5. Since inclusion