Intubation of Morbidly Obese Patients. A Randomized Clinical Trial, Comparing GlideScope ® With Fastrach TM.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of Patients Intubated in the First Attempt
研究概览
简要总结
The purpose of this study is to compare the GlideScope ® and the Fastrach TM for intubation of morbidly obese. Mainly we will try to clarify which of the instruments that produce the shortest intubationtime and lowest number of intubationattempts.
The hypothesis is that intubation would be 1) quicker and 2) with the lowest number of attempts, using the GlideScope®.
详细描述
The number of obese people rises. Thus 25.2% of Danish 9th graders are obese. As a result, surgery and anesthesia in obese patients becomes more frequent. Several potential problems related to anesthesia in this patient group exists, including airway management and sufficient oxygenation.
Anaesthesia of obese patients are more likely to require intubation. In light of the foregoing, it is therefore important to find the methods that provide the fewest complications related to intubation. Therefore this study compare two instruments (Fastrach TM and GlideScope ®) to find out which of the methods that provides the best airway management, measured primarily in time and numbers of intubation attempts.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI >/= 35
排除标准
- •need for crash induction.
结局指标
主要结局
Number of Patients Intubated in the First Attempt
时间窗: please see description
The intubation attempt was considered a failure if the GS or the FT was removed from the patient's mouth and required reinsertion or if the cuff had been inflated and the tube needed to be replaced (e.g., in oesophageal intubation).
Time to Intubate
时间窗: From when the anaesthetist picked up the GS / FT until a typical capnogram was seen on the capnograph.
次要结局
- Lowest Saturation During Intubation.(measured on the monitor)
- Mucosal Lesion(inspection during intubation and one hour postop.)
- Subjectively Intubation Difficulty(measured immediately on a visual analogue scale.)
- Intubation of the Esophagus.(detected immediately)
- Postoperative Hoarseness.(one hour postoperative.)
- Postoperative Throat Pain.(one hour postoperative)
研究者
Mogens Ydemann Nielsen
MD
Glostrup University Hospital, Copenhagen