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临床试验/NCT05417295
NCT05417295Unknown不适用

Position Related Bronchial Injury Caused by Bronchial Cuff of Double Lumen Endotracheal Tube

Kaohsiung Medical University Chung-Ho Memorial Hospital0 个研究点目标入组 60 人开始时间: 2022年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
Left bronchial mucosal injury

研究概览

简要总结

Double lumen endotracheal tubes (DLT) are wildly used to maintain independent lung ventilation during thoracic surgery. Our aim is to assess whether the DLT bronchial cuff inflated or not is associated with tube displacement and bronchial mucosal injury while changing position.

详细描述

Experiment group: Before changing from supine position to lateral position, inflate air into the bronchial cuff of double lumen endotracheal tube (DLT) and adjust cuff pressure to 25-30 mmHg.

Control group: Do not inflate air into the bronchial cuff before changing position.

Main result: Degree of left bronchial mucosal injury. Secondary result: Displacement of double lumen endotracheal tube after changing position.

All patients receive general anesthesia and are intubated with left DLT in the supine position. The fiberoptic bronchoscope is used to check the position via tracheal lumen of DLT. The bronchial lumen is placed at the left bronchus and the edge of bronchial cuff is visible by fiberscope.

Before changing position, the bronchial cuff of experiment group is inflated with air and adjusted cuff pressure to 25-30 mmHg. Both groups of patient's neck are fixed by neck collar in order to prevent displacement of DLT by neck rotation. After changing into lateral position, the assistant inflates 2 ml of into the bronchial cuff of control group and adjust cuff pressure to 25-30 mmHg. The investigator, blinded to the tube assignments, uses the fiberoptic bronchoscope to check position of the tube again via tracheal lumen of DLT and record the distance of displacement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients receive elective thoracoscopic wedge resection in the lateral position and are intubated with left side double lumen endotracheal tube.

排除标准

  • ASA status > III, coagulopathy, known airway damage, difficult intubation, tracheostomy, double lumen endotracheal tube is displaced during operation which interferes one lung ventilation and needs to be adjusted.

结局指标

主要结局

Left bronchial mucosal injury

时间窗: Before extubation

Degree of left bronchial mucosal injury is recorded via bronchoscope. Intact = 0 Redness = 1 Swelling = 2 hematoma = 3 Bleeding = 4

次要结局

  • Displacement of double lumen endotracheal tube(After changing into lateral position)

研究者

申办方类型
Other
责任方
Sponsor

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