A Comparison of Placement With the VivaSight Left-sided Double Lumen Tube With an Integrated Monitor/Camera Versus the Standard Left-sided Double Lumen Tube (DLT) With Fiberoptic Bronchoscopy in Patients Requiring One-lung Ventilation (OLV)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Intubation time
研究概览
简要总结
The VivaSight™-DLT is a new OLV (one lung ventilation) device that contains an embedded camera. Therefore, a potential advantage is the continuous assessment of DLT position through continuous monitoring of the camera. The embedded camera of VivaSight™-DLT is positioned at the tracheal opening of the double lumen tube. It allows for continuous monitoring of the carina and bronchial tube placement.
The purpose of this study is to determine if a double lumen tube (DLT) with an embedded video camera, the VivaSight DLT, can be used in similar fashion to the standard double lumen tube with fiberoptic bronchoscopy. More specifically, the investigators would like to know the difference in time to optimal position in the left bronchus between the VivaSight DLT and the standard DLT with fiberoptic bronchoscopy. In addition, the investigators would like to know if the embedded camera on the VivaSight DLT provides a view that will allow for the optimum position of the DLT in the left bronchus.
详细描述
The investigators will perform a prospective, randomized study in thoracic surgical patients undergoing one-lung ventilation where the patient will receive either the VivaSight DLT or standard left-sided DLT. Subjects will be selected and evaluated who are at least 18 years old, but no older than 90 years old.
The investigators will compare the intubation time for the VivaSight™-DLT with the intubation time for standard DLT. The intubation time parameters for the VivaSight™-DLT are the passage of the tube through the vocal cords and the confirmation of proper tube positioning by the embedded camera. Fiberoptic bronchoscopy is performed to reassess the proper tube positioning, however, this will not be counted for the intubation time in this group. For the standard DLT, the intubation time parameter begins similarly, on the passage of the tube through the vocal cords, but ends with the confirmation of the proper placement by fiberoptic bronchoscopy. In both groups, C-MAC blade is used to visualize the passage of the tube through the vocal cords. These intubation times will be tracked real-time in the operating room and will be based upon both observation as well as the verbal confirmation of the attending anesthesiologist.
The intubation time must be within 5 minutes. The intubation time required more than 5 minutes is considered as unsuccessful intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •At least 18 years of age
- •Adult patient undergoing scheduled thoracic surgery which requires double-lumen tube placement
排除标准
- •More than 90 years of age
- •Patients with emergency surgery
- •Prisoners
- •Patient who cannot provide their own consent
- •Patient refusal
- •Non-English speaking patients
研究组 & 干预措施
VivaSight DLT group
Thoracic surgery patient is intubated with VivaSight double-lumen tube (intubation with VivaSight double-lumen tube). The intubation time, duration between the passage of the tube through the vocal cords and the confirmation of proper tube positioning by the embedded camera, is recorded. The tube position is reconfirmed by fiberoptic bronchoscopy.
干预措施: intubation with VivaSight double-lumen tube (Device)
VivaSight DLT group
Thoracic surgery patient is intubated with VivaSight double-lumen tube (intubation with VivaSight double-lumen tube). The intubation time, duration between the passage of the tube through the vocal cords and the confirmation of proper tube positioning by the embedded camera, is recorded. The tube position is reconfirmed by fiberoptic bronchoscopy.
干预措施: fiberoptic bronchoscopy (Procedure)
Standard DLT group
Thoracic surgery patient is intubated with standard double-lumen tube (intubation with standard double-lumen tube). The intubation time, duration between the passage of the tube through the vocal cords and the confirmation of proper tube positioning by fiberoptic bronchoscopy, is recorded.
干预措施: fiberoptic bronchoscopy (Procedure)
Standard DLT group
Thoracic surgery patient is intubated with standard double-lumen tube (intubation with standard double-lumen tube). The intubation time, duration between the passage of the tube through the vocal cords and the confirmation of proper tube positioning by fiberoptic bronchoscopy, is recorded.
干预措施: intubation with standard double-lumen tube (Device)
结局指标
主要结局
Intubation time
时间窗: Within 5 minutes
We will compare the intubation time for the VivaSight double-lumen tube (DLT) with the intubation time for standard DLT.
次要结局
- Picture reliability of the embedded camera of VivaSight double-lumen tube(Within 10 hours)
研究者
Javier H Campos
Principle Investigator
University of Iowa