Laryngeal Morbidity After Endotracheal Intubation - Endoflex-tube Versus Use of Stylet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Postoperative hoarseness
研究概览
简要总结
This study is aimed at reducing the risk of hoarseness and damage to the vocal cords following general anaesthesia. Conventional endotracheal intubation with use of a stylet will be compared with the Endoflex tube. A conventional stylet enforced endotracheal tube is dirigible because of the stiffness gained by the addition of a stylet. In high risk rapid sequence intubation settings the enhanced dirigibility can be crucial, which is why most anaesthesiologists choose to add the stylet in these situations. A new endotracheal tube with a dynamic dirigible end called the Endoflex tube might prove to be a good alternative to the conventional stylet enforced endotracheal tube.
Study hypothesis: The Endoflex tube will reduce the risk of hoarseness after intubation when compared to the conventional stylet enforced endotracheal tube under optimal intubation conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Elective surgical patients who require an endotracheal tube during general anaesthesia.
- •Informed consent.
- •Legally competent.
- •Be able to understand Danish and be able to read the given information in Danish.
排除标准
- •Planned or former operation in or around the pharynx or the larynx.
- •Cancer, infection or sequelae in or around the pharynx or the larynx.
- •Use of a stomach tube before or during surgery.
- •Suspected difficult intubation.
研究组 & 干预措施
Endoflex tube
Use of Endoflex tube for intubation.
干预措施: Endoflex tube (Device)
Endotracheal tube with stylet
Use of conventional endotracheal tube with a stylet for intubation.
干预措施: Polyvinyl chloride endotracheal tube with a stylet (Device)
结局指标
主要结局
Postoperative hoarseness
时间窗: 1 hr postoperatively
次要结局
- Vocal cord sequelae(After 4 weeks)
- Intubation conditions(During and after intubation - on average 5 minutes)
- Intubation difficulty scale(During and after intubation - on average 5 minutes)
- Voice Range Profile(After 4 weeks)
- Multi Dimensional Voice Profile(After 4 weeks)
- Voice Handicap Index(72 hr postoperatively)
- Vocal cord sequelae(Preoperative - on average 12 hours before operation)
- Voice Range Profile(72 hours postoperatively)
- Multi Dimensional Voice Profile(Preoperative - on average 12 hours before operation)
- Voice Handicap Index(Preoperative - on average 12 hours before operation)
- Vocal cord sequelae(Within 24 hr postoperatively)
- Vocal cord sequelae(72 hours postoperatively)
- Multi Dimensional Voice Profile(Within 24 hr postoperatively)
- Multi Dimensional Voice Profile(72 hours postoperatively)
- Voice Handicap Index(After 4 weeks)
研究者
Martin Kryspin Soerensen
MD
Rigshospitalet, Denmark