CT-Guided Versus Traditional Selection of Double-Lumen Tube Size for One-Lung Ventilation in Thoracic Surgery: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The anesthesiologist performing the intubation will remain blinded to group allocation and will not be informed whether the selected DLT size was based on CT measurements or conventional demographic-based criteria.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Conventional Group
DLT size will be selected using standard clinical criteria based on patient demographics, according to institutional standard tables.
干预措施: Conventional Group (Control) (Other)
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.
干预措施: CT-Guided Group (Intervention) (Other)
结局指标
主要结局
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
时间窗: During the intraoperative period (at first attempt of double-lumen tube placement)
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.
次要结局
- Incidence of DLT replacement(Intraoperative period (from initial DLT placement until end of surgery))
- Time required for successful intubation(Intraoperative period (from DLT insertion to confirmed successful placement))
- Frequency of intraoperative hypoxia and peak airway pressure fluctuations(Intraoperative period (from DLT insertion to confirmed successful placement))
- Blinded assessment of surgeon satisfaction (lung isolation quality)(At the end of surgery (intraoperative assessment))
- Post-operative sore throat or airway trauma(24 hours post-extubation)