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Table 4 Secondary outcomes in the TTCOV19 study for the intention-to-treat population

From: TTCOV19: timing of tracheotomy in SARS-CoV-2-infected patients: a multicentre, single-blinded, randomized, controlled trial

 

Intention-to-treat population

(n = 150)

Early tracheotomy

(n = 72)

Late tracheotomy

(n = 78)

p-value

Difference between groups

Mean (95% CI)

Total number of days with sedation*

18.4 (11.8)

16.5 (9; 26)

n = 146

17.6 (10.7)

14 (9; 23)

n = 71

19.2 (12.7)

17 (8; 27)

n = 75

0.42

 − 1.59 (− 5.44; 2.29)

Total number of days in the intensive care unit

23.9 (15.1)

21 (12; 32)

n = 148

23.7 (15.3)

19 (12; 32)

n = 71

24.2 (14.9)

22 (12; 32)

n = 77

0.83

 − 0.546 (− 5.474; 4.289)

Days from intubation to tracheotomy

9.45 (4.08)

9 (7; 11)

n = 102

7.69 (3.31)

7 (5; 9)

n = 49

11.1 (4.1)

11 (8; 13)

n = 53

 < .0001

 − 3.38 (− 4.85; − 1.92)

Total number of days with sedation during the first 28 days

16.7 (8.5)

16.5 (9; 26)

n = 146

16.2 (8.0)

14 (9; 23)

n = 71

17.1 (8.9)

17 (8; 27)

n = 75

0.52

 − 0.910 (− 3.697; 1.886)

Total number of days in the intensive care unit during the first 28 days

19.5 (8.2)

21 (12; 28)

n = 148

19.1 (8.1)

19 (12; 28)

n = 71

19.9 (8.4)

22 (12; 28)

n = 77

0.55

 − 0.809 (− 3.526; 1.844)

Total number of days with mechanical ventilation during the first 28 days

17.7 (8.8)

18 (9; 28)

n = 150

17.2 (8.5)

16.5 (9; 27.5)

n = 72

18.1 (9.1)

20 (8; 28)

n = 78

0.57

 − 0.842 (− 3.639; 2.083)

Need of reintubation

19 (12.8%)

11 (15.5%)

8 (10.3%)

0.48

5.2 (− 6.9; 17.4)

Death in the intensive care unit

49 (32.7%)

20 (27.8%)

29 (37.2%)

0.29

 − 9.4 (− 25.6; 6.8)

Days from intubation to death

26.3 (15.6)

22.5 (13.5; 39)

n = 52

25.6 (16.5)

18 (11; 39)

n = 22

26.9 (15.2)

24.5 (17; 38)

n = 30

0.78

 − 1.31 (− 10.00; 7.36)

Type of tracheotomy

Open surgical

82 (81%)

40 (82%)

42 (81%)

  

Percutaneous

19 (19%)

9 (18%)

10 (19%)

0.99

 

Complications

Any complication

114 (76.0%)

53 (73.6%)

61 (78.2%)

0.64

 − 4.6 (− 19.6; 10.4)

Pulmonary embolism

17 (11.3%)

4 (5.6%)

13 (16.7%)

0.056

 − 11.1 (− 22.3; 0.0)

Pneumothorax

13 (8.7%)

6 (8.3%)

7 (9.0%)

1.00

 − 0.6 (− 11.0; 9.7)

Ventilator associated pneunomia

6 (4.0%)

3 (4.2%)

3 (3.8%)

1.00

0.3 (− 7.3; 7.9)

Airway obstruction

13 (8.7%)

9 (12.5%)

4 (5.1%)

0.19

7.4 (− 3.0; 17.8)

Tracheal bleeding

23 (15.3%)

11 (15.3%)

12 (15.4%)

1.00

 − 0.1 (− 13.0; 12.8)

Renal failure

23 (15.3%)

10 (13.9%)

13 (16.7%)

0.81

 − 2.8 (− 15.6; 10.1)

Stroke

5 (3.3%)

4 (5.6%)

1 (1.3%)

0.32

4.3 (− 2.9; 11.5)

Critical illness myopathy

15 (10.0%)

5 (6.9%)

10 (12.8%)

0.36

 − 5.9 (− 16.7; 4.9)

Delirium

26 (17.3%)

13 (18.1%)

13 (16.7%)

0.99

1.4 (− 12.1; 14.9)

Decubital ulcers

35 (23.3%)

15 (20.8%)

20 (25.6%)

0.62

 − 4.8 (− 19.6; 10.0)

Other complications

41 (27.3%)

21 (29.2%)

20 (25.6%)

0.76

3.5 (− 12.1; 19.1)

  1. Data are expressed as the mean (SD), median (IQR) or n (%)
  2. Early tracheotomy ≤ 7 days after intubation and late tracheotomy ≥ 10 days after intubation
  3. *Data for sedation were missing for four patients