Efferct of Standard Laryngoscopy Versus Video-laryngoscop on First-attempt Success in Difficult Airways Undergoing ProVu TM Video Stylet Guided Intubationa (PROVU)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Success rate on first intubation attemps
研究概览
简要总结
The aim of this open-label, randomized, 3-parallel arm trial is to compare success of intubation rate at first try between three groups that will be intubated:
- Conventional intubation with hyperangulated videolaryngoscope (control group),
- Intubation ProVu TM video stylet combined with hyperangulated videolaryngoscope,
- Intubation ProVu TM video stylet combined with standard Macintosh laryngoscope.
详细描述
Critical anesthetic incidents in the operating room are often related to airway management. Difficult airway management is defined as the clinical situation in which an anesthesiologist with conventional training has difficulty with upper airway face mask ventilation, difficulty with tracheal intubation, or both. Airway management has undergone a major transformation since the development of hyper-angle videolaryngoscopy (VL). Recently, the ProVuTM video stylet (Flexicare Medical Ltd, Mountain Ash, UK), which combines visualization technology with a tube guidance system, has been proposed as a new device for endotracheal intubation in participants with difficult airway management.
The investigators hypothesized that the ProVuTM video stylet combined with videolaryngoscopy or standard laryngoscopy may improve the success rate of intubation on the first attempt compared with using a videolaryngoscope alone in patientes with predicted difficult intubation. In fact, using ProVuTM the position of the video stylet tip can be adjusted continuously during the tracheal intubation maneuver.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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 undergoing elective surgery requiring oral tracheal intubation;
- •≥18 years of age;
- •simplified Arné score ≥11;
- •Written informed consent will be obtained from every participant.
排除标准
- •≤18 years of age
- •interincisor distance at maximal mouth opening ≤2 cm;
- •planned awake fiberoptic intubation because patients are patients considered to be high-risk for difficult intubation or difficult mask ventilation (e.g. with neck tumours, complete cervical arthrodesis; neck circumference >50 cm);
- •patients at risk of gastric aspiration
- •planned nasal intubation.
结局指标
主要结局
Success rate on first intubation attemps
时间窗: During the procedure
The first-attempt intubation success is defined as tracheal tube placement with a single maneuver after insertion of the tube in the mouth. Reinsertion of the tube in the mouth counts as an additional attempt.
次要结局
- Time of intubation(During the procedure)
- Number of intubation attempts(During the procedure)
- Complications(During the procedure)
- Use of "jaw trust" or "BURP"(During the procedure)
- Need of another anesthesiologist intervention(During the procedure)
- Time of laryngoscopy(During the procedure)
- Needs to change the path of the intubation strategy(During the procedure)
- Learning curve analysis of time of procedure(Through study completion, an average of 1 year)
- Learning curve analysis of intubation rate success(Through study completion, an average of 1 year)