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 |