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Table 2 Clinical outcomes

From: Effect of a self-developed fixation device on preventing endotracheal intubation-related pressure injury: a randomised controlled trial

Outcome

Observation group

(n = 51)

Control group

(n = 54)

p value

Primary outcome

Pressure injury on the lips, oral mucosa, or facial skin—no. of patients (%)

Rate of primary outcome (per 1000 patient ventilator days) (95% confidence interval)

4 (7.8)

16.8 (2.2, 31.5)

18 (33.3)

88.1 (57.5, 118.8)

0.001

 < 0.001

Lip pressure injury—no. (%)

Rate per 1000 patient ventilator days

0

0

14 (25.9)

63.8 (37.4, 90.2)

 < 0.001

 < 0.001

Oral–mucosal pressure injury—no. (%)

Rate per 1000 patient ventilator days

2 (3.9)

6.7 (−2.6, 16.0)

5 (9.3)

15.2 (2.0, 28.4)

0.481

0.532

Facial pressure injury—no. (%)

Rate per 1000 patient ventilator days

3 (5.9)

10.1 (−1.3, 21.4)

3 (5.6)

9.1 (−1.2, 19.4)

 > 0.999

 > 0.999

Secondary outcomes

Tube dislodgement—no. (%)

0

0

N/A

Ventilator-associated pneumonia—no. (%)

0

2 (3.7)

0.496

Duration of mechanical ventilation (days)

5.0 (3.0, 8.0)

5.0 (3.8, 8.3)

 > 0.999