Department of Anesthesiology, China-Japan Friendship Hospital, Beijing, China.
China-Japan Friendship Hospital, Beijing, China.
BMJ Open. 2024 Jan 2;14(1):e079841. doi: 10.1136/bmjopen-2023-079841.
Postoperative laryngopharyngeal discomfort after extubation can lead to severe throat pain, dysphagia, or postoperative tongue oedema. Possible mechanisms include increased oral pressure, obstruction of venous and lymphatic return in the neck, and increased capillary hydrostatic pressure, which leads to oedema of the tongue and upper airway. However, real-time monitoring indicators of anaesthesia are lacking. Therefore, we designed this study to accurately measure the contact force of the tracheal tube on the tongue in different surgical positions during general anaesthesia.
This prospective single-centre observational study will enrol 54 patients undergoing elective surgery under general anaesthesia for>2 hours with endotracheal tube application from 1 July 2023 to 30 June 2024. Patients will be divided into the supine () and high-risk () groups. Dynamic changes in the contact force between the tracheal tube and tongue will be measured using T-Scan technology. All patients will be followed up for 7 days postoperatively. The primary endpoint is postoperative laryngopharyngeal discomfort. Secondary outcomes include the time to the first successful recovery of oral intake of fluids and solid food, and airway-related events.
Ethical approval was obtained from the Ethics Committee of Clinical Research of China-Japan Friendship Hospital (2023-KY-219, approved on 14 September 2023). Informed consent will be obtained during anaesthesia evaluation. This study aims to explore the characteristics of the contact force on the tongue caused by endotracheal intubation in different surgical positions and to provide a better understanding of the risk factors and prevention of postoperative laryngopharyngeal discomfort. The findings of this study will be presented at our hospital, reported on ClinicalTrials.gov, and published in peer-reviewed journals.
NCT05987293.
拔管后咽喉不适可导致严重咽痛、吞咽困难或术后舌肿胀。可能的机制包括口腔压力增加、颈部静脉和淋巴回流受阻以及毛细血管静水压增加，导致舌和上呼吸道肿胀。然而，缺乏麻醉实时监测指标。因此，我们设计了这项研究，以准确测量全身麻醉期间不同手术体位下气管导管对舌的接触力。
这是一项前瞻性单中心观察研究，将纳入 2023 年 7 月 1 日至 2024 年 6 月 30 日期间因全身麻醉>2 小时并应用气管内导管行择期手术的 54 例患者。患者将分为仰卧位（）和高危（）组。使用 T-Scan 技术测量气管导管与舌之间的接触力的动态变化。所有患者将在术后 7 天内进行随访。主要终点是术后咽喉不适。次要结局包括首次成功恢复口服液体和固体食物的时间以及与气道相关的事件。
本研究已获得中日友好医院临床研究伦理委员会的批准（2023-KY-219，2023 年 9 月 14 日批准）。在麻醉评估期间将获得知情同意。本研究旨在探讨不同手术体位下气管插管引起的舌接触力特征，更好地了解术后咽喉不适的危险因素和预防措施。该研究的结果将在我院、ClinicalTrials.gov 上报告，并发表在同行评议的期刊上。
NCT05987293。
