CT-Guided vs Conventional DLT Sizing in Thoracic Surgery (CTDLT-SIZE)
2026年8月4日 更新者：King Hussein Cancer Center
CT-Guided Versus Traditional Selection of Double-Lumen Tube Size for One-Lung Ventilation in Thoracic Surgery: A Prospective Study
This is a prospective, randomized, single-blinded controlled trial designed to compare CT-guided versus conventional methods for selecting double-lumen tube (DLT) size in patients undergoing thoracic surgery requiring one-lung ventilation
研究概览
详细说明
This is a prospective, randomized, single-blinded controlled trial designed to compare CT-guided versus conventional methods for selecting double-lumen tube (DLT) size in patients undergoing thoracic surgery requiring one-lung ventilation. The study aims to evaluate whether preoperative computed tomography (CT)-based bronchial diameter measurement improves the accuracy of initial DLT size selection compared with conventional selection based on demographic parameters.
Eligible patients will be randomly assigned in a 1:1 ratio to either the CT-guided group or the conventional group.
研究类型
介入性
注册 (估计的)
100
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Moh'D Yousef, Consultant
- 电话号码：+962796420055
- 邮箱：MY.16674@KHCC.JO
研究联系人备份
- 姓名：Ahmad Al Kharabsheh, Fellow physician
- 电话号码：00962-796420055
- 邮箱：AA.15386@KHCC.JO
学习地点
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Amman、约旦、11941
- 招聘中
- King Hussein Cancer Center
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接触：
- Ahmad Al Kharabsheh, Fellow physician
- 电话号码：00962-796420055
- 邮箱：AA.15386@KHCC.JO
-
接触：
- Moh'D Yousef, MD
- 电话号码：+962796420055
- 邮箱：MY.16674@KHCC.JO
-
首席研究员：
- Dr. Moh'd Yousef, MD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Adult patients (≥18 years) scheduled for elective thoracic surgery requiring one-lung ventilation.
- Availability of preoperative thoracic CT imaging.
- Procedures requiring placement of a left-sided DLT.
- Patient who has a normal pulmonary function test.
Exclusion Criteria:
- Previous tracheal surgery
- Patient with difficult airway whom need bronchial blocker.
- Emergency thoracic procedures.
- Incomplete intraoperative or imaging data.
- Patient with severe obstruction or restriction.
- Pediatric patient
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：CT-Guided Group
Participants will undergo preoperative CT measurement of the bronchial diameter 10 mm distal to the carina.
DLT size will be selected using manufacturer-recommended correlation charts based on CT measurements.
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Participants will undergo preoperative CT measurement of the bronchial diameter 10 mm distal to the carina.
DLT size will be selected using manufacturer-recommended correlation charts based on CT measurements.
|
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有源比较器：Conventional Group
DLT size will be selected using standard clinical criteria based on patient demographics, according to institutional standard tables.
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DLT size will be selected using standard clinical criteria based on patient demographics, including sex, height, and weight, according to institutional standard tables.
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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 |
|---|---|---|
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Successful selection of the correct DLT size on the first attempt (defined as optimal position and lung isolation without the need for tube exchange) using fiberoptic scope
大体时间：During the intraoperative period (at first attempt of double-lumen tube placement)
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the correct placement of a double-lumen tube (DLT) on the first attempt, achieving optimal tracheobronchial position and effective lung isolation as confirmed by fiberoptic bronchoscopy, without the need for tube exchange or repositioning.
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During the intraoperative period (at first attempt of double-lumen tube placement)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of DLT replacement
大体时间：Intraoperative period (from initial DLT placement until end of surgery)
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Number of participants requiring replacement of the double-lumen tube (DLT) after initial placement due to incorrect size, malposition, or inadequate lung isolation
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Intraoperative period (from initial DLT placement until end of surgery)
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Time required for successful intubation
大体时间：Intraoperative period (from DLT insertion to confirmed successful placement)
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Time (in seconds) from insertion of the double-lumen tube into the mouth until successful tracheal placement and confirmation of correct positioning and lung isolation
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Intraoperative period (from DLT insertion to confirmed successful placement)
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Frequency of intraoperative hypoxia and peak airway pressure fluctuations
大体时间：Intraoperative period (from DLT insertion to confirmed successful placement)
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Incidence of episodes of intraoperative hypoxia and measurement of peak airway pressure fluctuations during one-lung ventilation.
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Intraoperative period (from DLT insertion to confirmed successful placement)
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Blinded assessment of surgeon satisfaction (lung isolation quality)
大体时间：At the end of surgery (intraoperative assessment)
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Surgeon satisfaction with lung isolation quality assessed using a standardized scoring scale, evaluated in a blinded manner at the end of the surgical procedure.
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At the end of surgery (intraoperative assessment)
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Post-operative sore throat or airway trauma
大体时间：24 hours post-extubation
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Incidence and severity of post-operative sore throat and/or signs of airway trauma (e.g., hoarseness, blood on suctioning, or mucosal injury if assessed) within 24 hours after extubation.
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24 hours post-extubation
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Moh'D Yousef, Consultant, Anesthesiology、King Hussein Cancer Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月15日
初级完成 (估计的)
2028年5月2日
研究完成 (估计的)
2028年8月1日
研究注册日期
首次提交
2026年5月4日
首先提交符合 QC 标准的
2026年5月4日
首次发布 (实际的)
2026年5月8日
研究记录更新
最后更新发布 (实际的)
2026年8月7日
上次提交的符合 QC 标准的更新
2026年8月4日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.