Prospective, Randomized Study in Ventilated Critically Ill Patients Receiving Percutaneous Tracheotomy. A Comparison of Periinterventional Visualization of Conventional Bronchoscopy and an Endotracheal Tube Mounted Camera (VivaSight-SL™)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- visualization through the tube camera of endotracheal landmark structures for tracheotomy and visualization of the needle insertion (according to score)
研究概览
简要总结
Optical guidance for percutaneous tracheotomy in intensive care is usually performed by bronchoscopy. Recently, an endotracheal tube with a camera mounted at its tip (VivaSight-SL) has been introduced that allows for endotracheal visualization.
For feasibility evaluation, ten patients in intensive care receive percutaneous tracheotomy with optical guidance by the VivaSight-SL tube. If this part is completed with satisfactory results, patients are randomized to receive optical guidance by bronchoscopy or by VivaSight-SL tube. The primary end point is the visualization through the tube camera of endotracheal landmark structures for tracheotomy and visualization of the needle insertion (according to score, see detailed description).
详细描述
Background
Long-term ventilated critically ill patients often receive a tracheotomy to facilitate weaning from the ventilator and for prevention of secondary complications by the endotracheal tube [1]. Besides surgical tracheotomy in which a muco-cutaneous fistula is prepared between trachea and outer skin, percutaneous tracheotomy (PDT) has been introduced, in which a cannula is being inserted into the trachea. After introduction of a guidewire, the trachea is then dilated [2]. This intervention should be led by optical guidance, i. e. to verify the correct point of tracheal cannulation between the 2nd and 3rd tracheal cartilage and to minimize the risk for accidental injury to the membranous part of the trachea [3]. Usually, optical guidance is performed by bronchoscopy [4]. During bronchoscopy in ventilated patients, a drop in minute ventilation or an increase of carbon dioxide partial pressure with a consecutive respiratory acidosis may occur. Recently, an endotracheal tube with an integrated camera at its tip has been introduced that permits a continuous visualization of the trachea on a monitor connected to the camera (VivaSightTM-SL, ETView Ltd., Misgav, Israel) [5]. This tube has been CE and FDA certified (http://www.etview.com/products/ vivasight-sl).
In this study, it is being evaluated whether the optical guidance during PDT can be performed by the VivaSightTM-SL tube. Without the need for bronchoscopy during intervention, patients' ventilation during the procedure may be optimized with a lesser increase of the arterial and the end-expiratory carbon dioxide partial pressures. Furthermore, the procedure itself would be simpler without the need for a bronchoscopy.
In the investigators' institution, the VivaSightTM-SL tube has already been used in two patients together with bronchoscopic guidance for percutaneous tracheotomy. According to the investigators' experience, it seems to be possible to perform the procedure without a bronchoscopy. Therefore, the feasibility of PDT with guidance by the VivaSightTM-SL tube alone without bronchoscopy is tested. After a positive result in the first part of this study, non-inferiority of the VivaSightTM-SL tube in comparison to bronchoscopy is tested.
Methods
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving percutaneous tracheotomy in the Dept. of Intensive Care Medicine.
- •Age ≥ 18 years
- •Informed consent
排除标准
- •Age < 18 years
- •No consent
- •Direct laryngoscopy according to Cormack-Lehane ≥ 3
研究组 & 干预措施
bronchoscopic guidance
optical guidance of percutaneous tracheotomy is done by conventional bronchoscopy
干预措施: conventional bronchoscopy (Device)
tube mounted camera guidance
optical guidance of percutaneous tracheotomy is done by the VivaSight-SL tube
干预措施: VivaSight-SL tube (Device)
结局指标
主要结局
visualization through the tube camera of endotracheal landmark structures for tracheotomy and visualization of the needle insertion (according to score)
时间窗: during tracheotomy
次要结局
- change in paCO2 values(three time points: baseline value (up to 1h before tracheotomy), 0 min before skin incision, and 0 min before insertion of tracheal cannula)
- change in paO2 values(three time points: baseline value (up to 1h before tracheotomy), 0 min before skin incision, and 0 min before insertion of tracheal cannula)
- duration of the intervention(during tracheotomy)
- change in etCO2 values(three time points: baseline value (up to 1h before tracheotomy), 0 min before skin incision, and 0 min before insertion of tracheal cannula)
- changes in peak airway pressure of ventilator(three time points: baseline value (before sterile drapes are applied), 0 min before skin incision, and 0 min before insertion of tracheal cannula)
- adverse events(up to 1 week)
- minute ventilation according to score generated from 4 point Likert scale at 2 time points(two time points: 1. during identification of landmark structures before puncture of trachea, 2. during puncture, dilatation and tracheotomy)
- pulse oxymetric oxygen saturation according to score generated from 4 point Likert scale at 2 time points(two time points: 1. during identification of landmark structures before puncture of trachea, 2. during puncture, dilatation and tracheotomy)
- change in pH-values(three time points: baseline value (up to 1h before tracheotomy), 0 min before skin incision, and 0 min before insertion of tracheal cannula)