A Comparison of the Performance of Standard Double Lumen Tubes With Vivasight DL™ Double Lumen Tubes for Lung Isolation in Patients Undergoing Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- John Laffey
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Adequacy of optical view obtained to confirm optimal tube position.
研究概览
简要总结
The investigators have performed a number of studies on novel airway devices. In this randomized controlled trial he investigators would like to compare the performance of a new double-lumen endotracheal tube incorporating internal camera (Vivasight DL) with a standard double lumen tube.
详细描述
Single lung ventilation is frequently carried out to facilitate surgery on the lungs and pleura. In most instances this is achieved by insertion of a double-lumen endotracheal tube and then selectively ventilating one lung or both. Precise positioning of these tubes is essential for optimal performance. It has become the standard of care to perform bronchoscopy to confirm tube position.
A new double lumen endotracheal tube (Vivasight DL) has recently been developed. It has all the features of a standard double lumen endotracheal tube but also incorporates an internal camera which, when connected to an external screen, allows continuous confirmation of tube position.
This is randomized, single blinded controlled trial. The participants will be allocated to two study groups (Vivasight DL or standard DLT), in which the primary airway management device will be respectively Vivasight DL double lumen tube or a standard double lumen endotracheal tube.
Clinical Research Ethics Committee approval has been obtained. Suitable participants will be recruited after written informed consent.
Standard anesthetic preassessment and anesthesia will be provided.
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
- 16 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16 - 85 yr old patients capable of informed consent
- •ASA (American Society of Anesthesiologists physical status) 1-3
- •non-emergency surgery of expected duration < 6 hours
- •one-lung ventilation required
排除标准
- •BMI > 35
- •expected difficult airway
- •Mallampati score >2
- •increased risk of aspiration
- •upper airway or upper GI problems
- •live pregnancy
结局指标
主要结局
Adequacy of optical view obtained to confirm optimal tube position.
时间窗: within 60 minutes of commencement of general anesthesia
The hypothesis is that the new Vivasight DL tube system will provide a comparable optical view to the fiberoptic scope view obtained via standard double lumen endotracheal tube in order to confirm optimal position.
次要结局
- Time to confirmation of tube position(within 60 minutes of commencement of general anesthesia)
- Operator rated Device Difficulty Score(within 60 minutes of commencement of general anesthesia)
- Time from initial laryngoscopy to passing tube through vocal cords(Within 60 minutes of commencement of general anesthesia)
- rate of malposition(within 15 hours of commencement of general anesthesia)
- need to pass a fiberoptic bronchoscope during case(within 15 hours of commencement of general anesthesia)
- presence of blood at the carina immediately post intubation(within 60 minutes of commencement of general anesthesia)
研究者
John Laffey
Professor of Anaesthesia and Critical Care, Consultant Anaesthetist
University College Hospital Galway