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Randomized Controlled Trial
. 2024 Mar 19;28(1):87.
doi: 10.1186/s13054-024-04874-7.

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

Xiaodong Zhang #  1 , Qibing Zhang #  1 , Jiqin You #  2 , Rong Xu #  1 , Zhaojie Zhang  1 , Yunlan Shi  1 , Chunrong Han  1 , Shiyan Zhao  1 , Bangtao Yao  3 , Yan Geng  4 , Songqiao Liu  5   6
Affiliations
Randomized Controlled Trial

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

Xiaodong Zhang et al. Crit Care. .

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.

Keywords: EIRPI; Endotracheal tube; Fixation; Lip; Pressure injury.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
A Structure diagram of the self-developed endotracheal tube fixation device. B Structure diagram of the traditional endotracheal tube fixation device. C Photograph of the patient wearing the self-developed endotracheal tube fixation device. D Photograph of the patient wearing the traditional endotracheal tube fixation device
Fig. 2
Fig. 2
Flow diagram of enrolment and randomisation of patients
See this image and copyright information in PMC

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