Prospective Randomized Study on Video Double-Lumen Tube Versus Double-Lumen Tube
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Number of Participants With Fiberoptic Use During Surgeries Requiring Lung Isolation
研究概览
简要总结
The goal of this clinical research study is to learn how often a fiberoptic bronchoscopy (FOB -- also known as a fiberoptic scope procedure) needs to be used with a video double lumen tube (VDLT) during surgeries that require lung isolation. On this study, you will have one of 2 types of commonly-used breathing tubes used, either a VDLT or a non-video double lumen tube (called a non-video DLT). An FOB may or may not be performed, as described below.
The level of effectiveness of the VDLT and non-video DLT will be compared.
详细描述
The difference between the 2 types of breathing tubes is that the VDLT has a built-in camera that is designed to allow the doctor to see the airways continuously.
A fiberoptic scope is a thin device that may be placed into the breathing tube in order to check that the tube is in the correct place.
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance of being assigned to either group.
If you are in Group 1, you will receive a non-video DLT for lung isolation before surgery. Once the doctor thinks the non-video DLT is in the correct place, its final position before surgery will be checked with an FOB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patients need lung isolation for purposed surgery
- •18 years or older
- •All patients to give written informed consent to participate
排除标准
- •Patient with known tracheobronchial anatomical anomalies
- •Patient requiring emergency operations
- •Patients with known difficult airways
- •Patients where other lung isolation devices may be warranted (tracheostomy, nasal intubation)
- •Patient requiring sizes not available in DLT or VDLT
- •Patients requiring a right sided VDLT or DLT
研究组 & 干预措施
Non-Video Double Lumen Tube (DLT) Group
Participants receive a non-video DLT for lung isolation before surgery. Once non-video DLT is in correct place, its final position before surgery checked with a fiberoptic bronchoscopy (FOB).
干预措施: Non-Video Double Lumen Tube (DLT) (Device)
Non-Video Double Lumen Tube (DLT) Group
Participants receive a non-video DLT for lung isolation before surgery. Once non-video DLT is in correct place, its final position before surgery checked with a fiberoptic bronchoscopy (FOB).
干预措施: Fiberoptic Bronchoscopy (FOB) (Procedure)
Video Double Lumen Tube (VDLT) Group
Participants receive a VDLT for lung isolation before surgery. Once VDLT is in correct place, its final position before surgery checked with the camera inside the tube.
干预措施: Video Double Lumen Tube (VDLT) (Device)
结局指标
主要结局
Number of Participants With Fiberoptic Use During Surgeries Requiring Lung Isolation
时间窗: During surgery (from induction to extubation), an average of 1 hour
The rate of FOB use for the VDLT arm and the Double-Lumenendobronchial Tubes (DLT) arm was calculated. The Fisher's exact test or chi-square test was used to evaluate the association between 2 categorical variables. Wilcoxon rank-sum test was used to evaluate the difference in a continuous variable. Rate of fiberoptic use with the Video Double-Lumen Tube (VDLT) during surgeries requiring lung isolation and to compare to the rate of Fiberoptic Bronchoscopy (FOB) use with the conventional DLT.
次要结局
- Number of Participants in Which Anesthesiologist Was Able to Forewarn/ Anticipate Dislodging of Endobronchial Cuff(1 Day)
- Dislodgement During Positioning and Surgery(During positioning, up to 30 minutes and during surgery (from induction to extubation), up to 1 hour)
- Quality of View Provided by the VDLT (Embedded Camera) vs. DLT (FOB) Using Grading System(During surgery (from induction to extubation), an average of 1 hour)