Nanjing Lishui People's Hospital, Zhongda Hospital Lishui Branch, Southeast University, Nanjing, 211200, China.
The Central Hospital of Xuzhou, Xuzhou, 221000, China.
Crit Care. 2024 Mar 19;28(1):87. doi: 10.1186/s13054-024-04874-7.
To evaluate the effects of our self-developed endotracheal tube fixation device in mechanically ventilated patients.
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).
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.
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.
评估我们自主研发的气管导管固定装置在机械通气患者中的效果。
在一项双中心随机对照试验中，预计需要机械通气超过 48 小时的患者被分配到观察组（使用自主研发的装置）或对照组（使用传统装置）。主要终点是气管插管相关压力性损伤（EIRPI）的发生率。
观察组 51 例患者和对照组 54 例患者纳入分析。观察组 EIRPI 发生率为 7.8%，对照组为 33.3%（p=0.001）。观察组 0 例患者发生唇压伤（PI），对照组 14 例（25.9%）（p<0.001）。观察组和对照组的口腔黏膜和面部 PI 发生率相似。
新型装置可降低 EIRPI 的发生率，尤其是唇 PI。
中国临床试验注册中心 ChiCTR2300078132。注册于 2023 年 11 月 29 日。
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