The VivaSight Double Lumen Tube Versus Conventional Double Lumen Tube in Thoracic Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Participants Requiring Flexible Fiberoptic Bronchoscopy
研究概览
简要总结
This prospective, randomized, comparative study is intended to enroll a total of 50 patients undergoing thoracic surgery that necessitates single lung ventilation. The efficacy and performance of the VivaSight DLT will be compared to the conventional double lumen tube. Use of fiberoptic bronchoscopy for initial tube positioning and subsequently during the case will be recorded. The attending thoracic surgeon will judge the quality of lung deflation. The occurrence of any malposition and subsequent maneuvers will be recorded. A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-90 years old
- •Scheduled for a thoracic surgery that requires single lung ventilation
- •Willing and able to consent in English or Spanish
排除标准
- •Age less than 18 or older than 90
- •Patient does not speak English or Spanish
- •Patient refusal
- •Pregnant or nursing women
- •Known or suspected difficult airway
- •Contraindication for left sided double lumen tube (e.g, L bronchial mass)
研究组 & 干预措施
Conventional Double Lumen Tube
Patient will be intubated with conventional double lumen endotracheal tube for single lung ventilation during thoracic surgery.
干预措施: Conventional Double Lumen Tube (Device)
VivaSight Double Lumen Tube
Patient will be intubated with VivaSight double lumen endotracheal tube for single lung ventilation during thoracic surgery.
干预措施: VivaSight Double Lumen Tube (Device)
结局指标
主要结局
Number of Participants Requiring Flexible Fiberoptic Bronchoscopy
时间窗: Intraoperative, within the time the double lumen was in the trachea
The number of participants requiring flexible fiberoptic bronchoscopy during double-lumen tube intubation for a single lung ventilation.
次要结局
- The Intubation Time(Intraoperative, time to successfully intubate patient.)
- Number of Participants With Malposition(Intraoperative, within the time the double lumen was in the trachea)
- The Cost of Double Lumen Tube Intubation(Intraoperative)
研究者
Tiffany B Moon
Associate Professor
University of Texas Southwestern Medical Center