成人患者胸腔镜手术中右侧可视双腔管的应用 (RIGHT-VDLT)
成人患者胸腔镜手术中右视双腔管与右普通双腔管的临床应用比较
本临床试验旨在了解视觉双腔插管与标准双腔插管相比,是否能提高首次尝试成功率并减少并发症。 试验主要旨在回答以下问题:
双腔插管是否能提高首次尝试成功率?
视觉双腔插管是否能降低右上叶支气管开口阻塞的可能性?
视觉双腔插管在手术期间是否需要更少的调整?
与使用标准双腔插管的患者相比,使用视觉双腔插管的患者是否经历更少的围手术期并发症?
参与者将:
部分使用视觉双腔插管,部分使用标准双腔插管。
记录所有患者的围手术期状态。
研究概览
地位
详细说明
Right-sided double-lumen tubes are used to achieve lung isolation and one-lung ventilation during thoracoscopic surgery. Accurate positioning is particularly important because of the short right main bronchus and the need to maintain patency of the right upper-lobe bronchial opening. Malposition or displacement of a right-sided double-lumen tube may impair right upper-lobe ventilation, compromise lung isolation, and require repeated tube repositioning or fibreoptic bronchoscopy.
This prospective, multicentre, parallel-group randomised controlled trial will enrol 566 adult participants undergoing elective thoracoscopic surgery requiring one-lung ventilation with a right-sided double-lumen tube. Participants will be randomly allocated in a 1:1 ratio to either a video-guided right-sided double-lumen tube or a conventional right-sided double-lumen tube.
In the video-guided group, an integrated visualisation system provides continuous airway visual feedback during initial tube positioning and intraoperative monitoring, allowing real-time identification of changes in tube position. In the conventional group, initial tube placement is performed using standard clinical techniques and anatomical landmarks.
After initial positioning, final tube position will be confirmed by fibreoptic bronchoscopy in both groups. Subsequent fibreoptic bronchoscopy during one-lung ventilation will be performed only when clinically indicated or according to predefined rescue criteria.
The primary outcome is successful initial right-sided double-lumen tube placement, defined as placement of the assigned tube on the first intubation attempt with satisfactory final tube position and satisfactory lung isolation, without withdrawal and reinsertion or exchange to another airway device before initiation of one-lung ventilation.
Secondary outcomes include the incidence of right upper-lobe bronchial obstruction confirmed by fibreoptic bronchoscopy; incidence of intraoperative double-lumen tube displacement; incidence of hypoxemia during one-lung ventilation; requirement for rescue fibreoptic bronchoscopy; time to satisfactory right-sided double-lumen tube positioning; quality of operative lung collapse assessed by the operating surgeon; and the number of intraoperative tube repositioning events.
Participants and outcome assessors will remain blinded to treatment allocation. Because the video-guided and conventional right-sided double-lumen tubes have distinct visual and operational characteristics, the anaesthesiologist performing tracheal intubation and other intraoperative personnel directly involved in airway management cannot be blinded. Outcome assessment will be performed by personnel who are not involved in the airway intervention and remain unaware of treatment allocation.
The trial is designed to determine whether continuous airway visualisation improves initial placement success, maintains more stable right-sided double-lumen tube positioning, reduces the need for subsequent airway interventions, and improves clinically relevant conditions during one-lung ventilation.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Heng Wen
- 电话号码:+8615158080827
- 邮箱:zyyywenheng@zju.edu.cn
学习地点
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国、310000
- 招聘中
- The First Affiliated Hospital, Zhejiang University School of Medicine,
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接触:
- Heng Wen
-
Jiaxing、Zhejiang、中国、314000
- 招聘中
- Affiliated Hospital of Jiaxing University(The First Hospital of Jiaxing)
-
Jiaxing、Zhejiang、中国、314000
- 尚未招聘
- The Second Affiliated Hospital of Jiaxing University(The Second Hospital of Jiaxing)
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
纳入标准:
- 年龄:至少18岁,性别不限。
- 美国麻醉医师协会(ASA)分级I-III级;
- 择期视频辅助胸腔镜肺叶切除术。
- 患者或家属知情同意。
- 愿意接受围手术期访视的人员。
排除标准:
- 有右侧双腔管插入禁忌症的患者(如右侧支气管肿瘤)。
- 患者已知存在气管支气管解剖异常。
- 先前诊断或疑似存在气道困难的患者。
- 需要快速顺序诱导的患者。
- 需要紧急手术的患者。
- 过去四周内曾接受胸部手术、全身感染或疑似结核病的患者。
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Video-guided right-sided double-lumen tube
Participants undergo lung isolation for thoracoscopic surgery using a video-guided right-sided double-lumen tube.
The integrated camera provides continuous airway visualisation to facilitate initial positioning and intraoperative detection of tube displacement.
Final tube position is confirmed by fibreoptic bronchoscopy after initial positioning.
Subsequent fibreoptic bronchoscopy during one-lung ventilation is performed only when clinically indicated or according to predefined rescue criteria.
|
A right-sided double-lumen tube with an integrated visualisation system that provides continuous airway visual feedback during placement and intraoperative monitoring.
Fibreoptic bronchoscopy is used to confirm final tube position after initial positioning and remains available as a rescue technique when clinically indicated.
|
|
有源比较器:Conventional right-sided double-lumen tube
A conventional right-sided double-lumen tube used for lung isolation.
Initial placement is performed using standard clinical techniques and anatomical landmarks.
Fibreoptic bronchoscopy is used to confirm final tube position after initial positioning and remains available as a rescue technique when clinically indicated.
|
A conventional right-sided double-lumen tube used for lung isolation.
Initial placement is performed using standard clinical techniques and anatomical landmarks.
Fibreoptic bronchoscopy is used to confirm final tube position after initial positioning and remains available as a rescue technique when clinically indicated.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Successful initial right-sided double-lumen tube placement
大体时间:From initial insertion of the assigned right-sided double-lumen tube until confirmation of satisfactory tube position before initiation of one-lung ventilation (approximately 10 minutes).
|
Successful initial placement is defined as placement of the assigned right-sided double-lumen tube on the first intubation attempt, with satisfactory final tube position and satisfactory lung isolation, without withdrawal and reinsertion or exchange to another airway device before initiation of one-lung ventilation.
|
From initial insertion of the assigned right-sided double-lumen tube until confirmation of satisfactory tube position before initiation of one-lung ventilation (approximately 10 minutes).
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of right upper-lobe bronchial obstruction
大体时间:After initial tube positioning and before initiation of one-lung ventilation (approximately 10 minutes).
|
Right upper-lobe bronchial obstruction is defined as partial or complete obstruction of the right upper-lobe bronchial opening by the bronchial lumen or bronchial cuff after initial tube positioning, as confirmed by fibreoptic bronchoscopy.
The outcome will be recorded as present or absent.
|
After initial tube positioning and before initiation of one-lung ventilation (approximately 10 minutes).
|
|
Incidence of intraoperative double-lumen tube displacement
大体时间:From initiation of one-lung ventilation until completion of one-lung ventilation.
|
Tube displacement is defined as any intraoperative displacement of the double-lumen tube that requires repositioning to restore satisfactory tube position, ventilation, or lung isolation.
The outcome will be recorded as present or absent.
|
From initiation of one-lung ventilation until completion of one-lung ventilation.
|
|
Incidence of hypoxemia during one-lung ventilation
大体时间:During one-lung ventilation.
|
Hypoxemia is defined as peripheral oxygen saturation (SpO₂) <90% during one-lung ventilation.
The outcome will be recorded as present or absent.
|
During one-lung ventilation.
|
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Requirement for rescue fibreoptic bronchoscopy
大体时间:From completion of initial tube positioning until completion of one-lung ventilation.
|
Rescue fibreoptic bronchoscopy is defined as fibreoptic bronchoscopy performed after initial tube positioning because of suspected tube malposition, inadequate lung isolation, ventilation abnormality, or need for tube repositioning.
The outcome will be recorded as present or absent.
|
From completion of initial tube positioning until completion of one-lung ventilation.
|
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Time to satisfactory right-sided double-lumen tube positioning
大体时间:During initial tube placement after anaesthesia induction (approximately 10 minutes).
|
Time from removal of the stylet after the bronchial cuff passes the vocal cords to confirmation of satisfactory right-sided double-lumen tube position.
The duration will be recorded in seconds.
|
During initial tube placement after anaesthesia induction (approximately 10 minutes).
|
|
Quality of operative lung collapse
大体时间:20 minutes after initiation of one-lung ventilation.
|
The operating surgeon, blinded to treatment allocation, will assess operative lung collapse using a three-category scale: excellent (complete collapse with optimal surgical exposure), good (minor residual inflation without interference with surgery), or poor (incomplete collapse interfering with surgical exposure).
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20 minutes after initiation of one-lung ventilation.
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Number of intraoperative double-lumen tube repositioning events
大体时间:From initiation of one-lung ventilation until completion of one-lung ventilation.
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The number of separate tube repositioning procedures required after satisfactory initial placement will be recorded for each participant.
|
From initiation of one-lung ventilation until completion of one-lung ventilation.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- ZJU2025C144
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
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