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

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.