Table 3 Secondary outcomes

Ventilator-free days, days (median, IQR) ^a

MD (95% CI)

 From randomization to D28

15.5 (0.0–23.0)

0.0 (0.0–20.5)

3.0 (0.0–11.0)

 From randomization to D90

75.5 (36.0–85.0)

35.5 (0–82.5)

8.0 (0.0–48.0)

Time to first extubation, days (median, IQR), n

3.7 (1.9–4.9), 25

4.4 (1.9–7.9), 26

− 1.0 (− 3.0–0.8)

Time to successful extubation, days (median, IQR), n^a

4.2 (1.7–8.7), 23

3.9 (2.3–7.9), 20

0.1 (− 2.2–2.1)

Duration of MV, days (median, IQR)^a

4.9 (2.8–15.7)

9.8 (3.6–106.3)

− 3.0 (− 8.6–0.4)

Combined CMV mode hours, (median, IQR), n

61.0 (33.0–118.0), 35

69.0 (38.0–128.0), 37

− 6.0 (− 33.0–22.0)

Duration of NIV to D28, h (median, IQR), n

23.0 (9.5–106.3), 4

28.0 (5.0–41.0), 8

− 0.5 (− 24.0–106.0)

ICU stay, days (median, IQR)

9.1 (6.0–21.9)

14.8 (7.0–33.1)

− 3.3(− 8.8–1.1)

Hospital stay, days (median, IQR)

19.9 (11.9–42.8)

26.6 (11.3–61.1)

− 4.0 (− 14.9–5.0)

RR (95% CI)

NIV within 48 h post-extubation, n (%)

4/25 (16.0)

6/26 (23.1)

0.7 (0.2–2.0)

ICU mortality, n (%)

8/39 (20.5)

15/38 (39.5)

0.5 (0.3–1.1)

Hospital mortality, n (%)

9/39 (23.1)

19/38 (50.0)

0.5 (0.2–0.9)

Ventilator-associated pneumonia, n (%)

12/39 (30.7)

10/38 (26.3)

1.2 (0.6–2.4)

Pneumothorax, n (%)

1/39 (2.6)

0/38 (0.0)

1.2 (0.6–72.4)

Self extubation, n (%)

3/39 (7.7)

2/38 (5.3)

1.5 (0.3–7.1)

Participants with failed extubation, n (%)

6/25 (24.0)

7/26 (26.9)

0.9 (0.4–2.2)

Participants with reintubation, n (%)

7/25 (28.0)

9/26 (34.6)

0.8 (0.4–1.8)

Tracheostomy, n (%)

10/39 (25.6)

11/38 (29.0)

0.9 (0.4–1.8)