A Randomized Controlled Study Comparing the VivaSight Double-lumen Tube With a Conventional Double-lumen Tube in Adult Patients Undergoing Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ambu A/S
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Number of Times Bronchoscope is Used
研究概览
简要总结
The aim of this study is to make a health economic evaluation comparing novice physicians use of VivaSight double-lumen tube and a conventional double-lumen tube for single-lung ventilation during thoracic surgery at a teaching hospital. The hypothesis is, that both double-lumen tubes are equally cost-effective and the the incidence of fiberoptic bronchoscope use it the same for both tubes.
详细描述
A randomized, controlled single-centre investigation comparing the VivaSight double-lumen tube and the conventional double-lumen tube at a teaching hospital. A pilot study including up to 10 subjects will be performed prior to the investigation is initiated. The investigation will include a total of 50 adult subjects (25 subjects in each group) admitted to the investigational site with established indication of single lung ventilation.
The objective of the investigation is to compare the number of times the tube position needs to be verified with a scope and relevant costs between VivaSight double lumen tube and conventional double lument tube in a cost-effectiveness analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
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
- •Oral explanation of the investigation and Patient Information has been given to the subject or legal representative
- •The subject or legal representative has signed the Informed Consent
- •The subject is admitted at Odense University Hospital (OUH), department V
- •Subjects evaluated as eligible for single-lung ventilation with the use of a left sided DLT
- •Subjects > 18 years of age
排除标准
- •Subjects with known tracheobronchial anatomic anomalies
- •Subjects going for emergency procedures
- •Subjects with anticipated difficult airways
- •Subjects with known tracheal pathology
- •Subjects requiring rapid sequence induction
- •Surgeries in which other lung isolation devices or techniques may be warranted (e.g. tracheostomy, nasal intubation, bronchial blockers)
- •Subjects who cannot be intubated with a double-lumen tube (VivaSight-DL or conventional DLT)
- •Subjects requiring a right-sided DLT
- •Subjects who had participated in the study before
结局指标
主要结局
Number of Times Bronchoscope is Used
时间窗: During procedure, up to 4 hours
次要结局
- Intubation Time(During procedure, up to 4 hours)
- Number of Time the Tube Was Repositioned(During procedure, up to 4 hours)
- Number of Times Repositioning of the Tube Was Prevented(During procedure, up to 4 hours)
- Number of Intubation Attempts(During procedure, up to 4 hours)
- Cost Per Procedure(An average of 1 year)