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

ABSTRACT

OBJECTIVE: To evaluate the effects of our self-developed endotracheal tube fixation device in mechanically ventilated patients. METHODS: In a dual-centre randomised controlled trial, patients who were expected to require mechanical ventilation for over 48 h were assigned to the observation group (using self-developed device) or the control group (using the traditional device). The primary endpoint was the incidence of endotracheal intubation-related pressure injury (EIRPI). RESULTS: Fifty-one patients in the observation group and 54 patients in the control group were analysed. The incidence of EIRPI was 7.8% in the observation group and 33.3% in the control group (p = 0.001). Lip pressure injury (PI) occurred in 0 versus 14 (25.9%) patients in the observation versus control groups (p < 0.001). Both oral-mucosal and facial PIs were similar between the two groups. CONCLUSIONS: The use of the novel device reduced the incidence of EIRPI, especially lip PI. Trial registration Chinese Clinical Trial Registry ChiCTR2300078132. Registered on 29 November 2023.