Prospective, Randomized Clinical Trial Evaluating the ETView Double-Lumen Tube
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- time to intubation
研究概览
简要总结
No prospective randomized clinical trial assessed the performance of this new device in a clinical setting. Consequently the aim of this study is to determine clinical performance of this new device compared with conventional DLT.
- Trial with medical device
详细描述
In several clinical situations and surgical procedures single-lung ventilation (SLV) is essential. Especially during thoracic surgery SLV and collapse of the operated lung, while ventilating the other side of the lung is the most frequented indication. In these cases the double lumen tube (DLT) is the most widely used device.
The DLT consists of a proximal tracheal and a distal bronchial end, reaching into the left or the right side of the lung- dependent of the model of the tube. Endotracheal intubation with DLT, which are much larger and stiffer than conventional single-lumen tubes, are much more difficult to place and are especially likely to provoke airway injuries. Furthermore, placement of a DLT requires obligatory fiberoptic bronchoscopy and a certain level of experience. Tube misplacement after patients removal from dorsal (intubation-) to lateral position as well as during surgical procedure is relatively frequent. Tube displacement from its proper position above the carina, respectively in the main bronchus, may result in life-threating complications and airway lacerations.
The anesthetist may detect tube misplacement from indirect clinical signs including increased airway pressure, oxygen desaturation, or difficulty performing SLV. In this clinical situations, verification of tube position using fibreoptic bronchoscopy is indicated. Fibreoptic bronchoscopy requires rigorous training and practice to maintain a high level of skill as well as expensive infrastructure.
The VivaSight-DL (ETView Ltd, M.P. Misgav 20174, Israel) is a new DLT promising to exceed clinical performance of the conventional DLT. The VivaSight-DL is basically a left-sided DLT with an embedded video imaging device and light source at its tip and integrated cable with connector. However, after correct tube placement, the video imaging device is focused on the main carina, indicating the correct position of the bronchial cuff in the left main bronchus.
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
- None
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
- •Elective thoracic surgery with anticipated use of a DLT
- •Anticipated extubation in the operating room;
- •American Society of Anesthesiologist Physical Status 1-3;
- •Written consent (signature from patient)
排除标准
- •Tracheal pathology, including tracheostomy;
- •Any form of infection (including upper-respiratory tract infection or pneumonia) or suspected tuberculosis;
- •BMI higher exceeding 40 kg/m2;
- •Known or suspected difficult airway.
- •Pregnancy
- •Breast feeding
- •The subject must not be involved in any other clinical trial during the course of this trial, nor within a period of 30 days prior to its beginning or 30 days after its completion
研究组 & 干预措施
ET View Double Lumen Tube
Patients assigned to the thisgroup will be intubated using the VivaSight-DL.
干预措施: ET View Double Lumen Tube (Device)
conventional Double Lumen Tube
Patients assigned to the first group will be intubated using conventional DLT (Bronchocath, left sided; Rüsch, Kernen, Germany).
干预措施: conventional Double Lumen Tube (Device)
结局指标
主要结局
time to intubation
时间窗: 300 seconds
Time for intubation, defined as "time from insertion of the laryngoscope until statement of the intubating anesthesiologist, that DLT was correctly placed". Time for intubation will be measured by an independent researcher using a stop watch.
次要结局
- Rate of misplacement(3 hours)
- Quality of lung collapse(3 hours)
- Airway injuries(3 hours)
- Postoperative coughing(24 hours)
- Postoperative hoarseness(24 hours)
- Postoperative sore throat(24 hours)
- Rate of blind insertion(300 seconds)
- rate of fibreoptic bronchoscopy(3 hours)