Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Force(newton)
研究概览
简要总结
Percutaneous dilatational tracheostomy (PDT), especially single-step dilatational tracheostomy (sd-PDT), is now frequently preferred to surgical tracheostomy. Occasionally, it needs a second dilation maneuver .Dissection of the deep cervical fascia during PDT, known as reformative PDT (re-PDT), may facilitate the procedure. This study was designed to compare re-PDT with sd-PDT in ICU patients
详细描述
Percutaneous dilatational tracheostomy (PDT) is a popular airway management technique in the intensive care unit (ICU).Occasionally the first dilation may be challenging when using Ciaglia and colleagues' method, and a second dilation may be needed to insert the tracheostomy tube. In these circumstances, potentially life-threatening complications, such as hemorrhage and hypoxia, may arise. The investigators found the reasons for difficulty in achieving smooth dilation of the stoma.The investigators compared the traditional method with the improved method.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 44 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years;
- •requirement for long-term mechanical ventilation;
- •failure of weaning from mechanical ventilation.
排除标准
- •age <18 years;
- •pre-existing infection at the tracheostomy site;
- •pre-existing malignancy at the tracheostomy site;
- •difficulty in identifying the anatomic landmarks;
- •unstable cervical spine fracture;
- •international normalized ratio (INR) >2;
- •platelet count <50 000 mm3.
研究组 & 干预措施
sd-PDT group
The investigators applied the traditional standard dilation technique when operating tracheostomy on the standard group.
干预措施: reformative dilation technique (Procedure)
re-PDT group
The investigators applied the reformative dilation technique when operating tracheostomy on the re-PDT group.
干预措施: reformative dilation technique (Procedure)
结局指标
主要结局
Force(newton)
时间窗: Intraoperative (Force was measured the exact moment when investigators insert the'J' guidewire)
Force refers to the force needed to dilate the airway and measured by force gauge
次要结局
- Time(seconds)(Time was measured from tracheal puncture to tracheal tube placement, 180 seconds maxime)
研究者
Jinhai Li
attending physician
The First Affiliated Hospital with Nanjing Medical University