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Table 5 Secondary outcomes in the TTCOV19 study for the per-protocol population

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

 

Per protocol population

Early tracheotomy

Late tracheotomy

p-value

Difference between groups

(n = 61)

(n = 27)

(n = 34)

Mean (95% CI)

Total number of days with sedation*

23.8 (9.9)

19.7 (9.4)

27.3 (9.1)

0.0025

 − 7.61 (− 12.50; − 2.88)

22 (17,31)

18 (12;29)

26 (19.5;33)

  

n = 59

n = 27

n = 32

  

Total number of days in the intensive care unit

30.2 (13.9)

26.5 (15.2)

33.1 (12.3)

0.059

 − 6.67 (− 13.64; 0.23)

29 (22;37)

24 (14;35)

29.5 (24;40)

  

Days from intubation to tracheotomy

9.77 (4.73)

5.48 (1.37)

13.2 (3.5)

 < .0001

 − 7.69 (− 9.12; − 6.33)

10 (6;12)

6 (4;7)

12 (11;14)

  

Total number of days with sedation during the first 28 days*

21.4 (6.6)

18.3 (7.3)

24.0 (4.5)

0.0006

 − 5.70 (− 8.81; − 2.57)

22 (17; 28)

18 (12; 28)

26 (19.5; 28)

  

n = 59

n = 27

n = 32

  

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

23.9 (5.7)

21.2 (7.1)

26.0 (3.1)

0.0018

 − 4.81 (− 7.50; − 2.08)

28 (22; 28)

24 (14; 28)

28 (14; 28)

  

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

22.6 (6.3)

19.5 (7.4)

25.1 (3.7)

0.0006

 − 5.61 (− 8.50; − 2.69)

25 (18; 28)

18 (12; 28)

27 (22; 28)

  

Need for reintubation

7 (11.5%)

2 (7.4%)

5 (14.7%)

0.64

 − 7.3 (− 24.8; 11.2)

Death in the intensive care unit

26 (42.6%)

9 (33.3%)

17 (50.0%)

0.3

 − 16.7 (− 40.3; 9.0)

Days from intubation to death

30.3 (15.3)

23.9 (15.9)

33.6 (14.4)

0.12

 − 9.67 (− 22.83; 2.20)

28 (18;39)

13 (11;34)

28.5 (24;41)

  

n = 27

n = 9

n = 18

  

Type of tracheotomy

Open surgical

52 (85.2%)

24 (88.9%)

28 (82.4%)

  

Percutaneous

9 (14.8%)

3 (11.1%)

6 (17.6%)

0.47

 

Complications

Any complication

55 (90.2%)

23 (85.2%)

32 (94.1%)

0.46

 − 8.9 (− 28.1; 7.8)

Pulmonary embolism

9 (14.8%)

1 (3.7%)

8 (23.5%)

0.063

 − 19.8 (− 38.1; − 1.9)

Pneumothorax

7 (11.5%)

3 (11.1%)

4 (11.8%)

1

 − 0.7 (− 17.9; 18.4)

Ventilator associated pneumonia

3 (4.9%)

1 (3.7%)

2 (5.9%)

1

 − 2.2 (− 17.1; 14.3)

Airway obstruction

9 (14.8%)

6 (22.2%)

3 (8.8%)

0.27

13.4 (− 5.3; 34.5)

Tracheal bleeding

14 (23.0%)

6 (22.2%)

8 (23.5%)

1

 − 1.3 (− 23.1; 21.3)

Renal failure

10 (16.4%)

3 (11.1%)

7 (20.6%)

0.52

 − 9.5 (− 28.6; 11.1)

Stroke

2 (3.3%)

1 (3.7%)

1 (2.9%)

1

0.8 (− 12.1; 16.3)

Critical illness myopathy

8 (13.1%)

1 (3.7%)

7 (20.6%)

0.11

 − 16.9 (− 34.8; 1.2)

Delirium

15 (24.6%)

6 (22.2%)

9 (26.5%)

0.94

 − 4.2 (− 26.5; 18.9)

Decubital ulcers

22 (36.1%)

8 (29.6%)

14 (41.2%)

0.51

 − 11.5 (− 35.1; 14.3)

Other complications

20 (32.8%)

9 (33.3%)

11 (32.4%)

1

1.0 (− 23.0; 25.2)

  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 two patients