Videolaryngoscopy Versus Direct Laryngoscopy for Positioning the Tracheal Tube During Percutaneous Tracheostomy: A Randomized Controlled Trial (VIDLARTRAQUEO).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Introduction of the Seldinger needle below the endotracheal tube
研究概览
简要总结
When preparing an ICU patient for percutaneous dilational tracheostomy, correct positioning of the endotracheal tube is important. During the procedure, it is possible to puncture the cuff. Tracheal tube cuff puncture can lead to failure of ventilation, loss of positive end-expiratory pressure, and possible aspiration of gastric contents blood or secretions. To minimize the risk, in our ICU, we withdraw the endotracheal tube under direct laryngoscopic vision until the cuff is visible at the vocal cords. This maneuver would also facilitate insertion of the Seldinger needle and insertion of the tracheostomy tube below the endotracheal tube. However, this maneuver to remove the endotracheal tube under direct laryngoscopy can sometimes be difficult. ICU patients present frecuently difficult laryngoscopic vision due to airway edema or secretions. In ICU, the videolaryngopy has been shown to be superior to direct laryngoscopy in visualization the upper airway, allowing better laryngoscopic vision.
详细描述
The investigators aim to compare C-MAC videolaryngoscopy versus conventional direct laryngoscopy for positioning the tracheal tube to facilitate insertion of the Seldinger needle and the tracheostomy tube below the endotracheal tube during percutaneous tracheostomy.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU intubated patients that require a percutaneous dilational tracheostomy for clinical reasons (prolonged mechanical ventilation, airway protection or weaning failure).
排除标准
- •Patients younger than 18 years and older than 85 years
- •Trachea and neck abnormalities.
- •Soft tissue infection in the neck.
- •History of neck surgery.
- •Coagulation disorders or changes in coagulation parameters (platelet count < 50.000 mm3, an activated partial thromboplastin time 1.5-fold longer than the control value, and international normalized ratio > 1.5).
- •Consent refusal for participating in the trial.
结局指标
主要结局
Introduction of the Seldinger needle below the endotracheal tube
时间窗: during the procedure
Percentage of patients in whom the introduction of the Seldinger needle is below the tip of the endotracheal tube
次要结局
- Complications(during the ICU stay)
- patients who need to remove the endotracheal tube to introduce the percutaneous tracheostomy cannula(during the procedure)
- Laryngoscopy vision using de Modified Cormack-Lehane grade of glottic view(during the procedure)
- Difficulty of performing percutaneous tracheotomy(during the procedure)
- Puncture of the cuff of the endotracheal tube with the Seldinger needle(during the procedure)
- Difficulty of removing the endotracheal tube(during the procedure)
研究者
Manuel Taboada Muñiz
Clinical Professor
Hospital Clinico Universitario de Santiago