Evaluation and Comparison of the New Single Use Ambu aScope With Olympus BF 160 Multiple Use Scope for Securing the Airway of the Anaesthetised/Awake Patients' Normal or Difficult Airway
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- time for completion of intubation
研究概览
简要总结
The study is in two parts
Part one of the study describes the use of the new single-use flexible video-scope for intubation of patients with predicted normal airways.
Part two compares the performance of the single-use flexible video-scope with that of a conventional flexible video-scope for awake intubation of patients with predicted difficult airways.
The hypothesis is that the new single-use flexible video-scope for intubation performs as well as the traditional scope.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study part 1:
- •Patients scheduled for tracheal intubation and predicted to have a normal airway
- •ASA class I, II or III
- •>18 years
- •Study part 2:
- •Adult patients scheduled for tracheal intubation and predicted to have a difficult airway
- •ASA class I, II or III
- •>18 years
排除标准
- •Study part 1:
- •Massive bleeding from the mouth
- •Previously abandoned flexible optical intubation
- •Study part 2:
- •Massive bleeding from the mouth
- •Previously abandoned flexible optical intubation
- •Patients with audible stridor
- •Patients with dyspnea
研究组 & 干预措施
Conventional flexible videoscope for intubation
干预措施: tracheal intubation with a single use flexible videoscope (Procedure)
Single-patient flexible endoscope
Single-patient flexible video-endoscope used for tracheal intubation in this intervention-arm
干预措施: tracheal intubation with a single use flexible videoscope (Procedure)
结局指标
主要结局
time for completion of intubation
时间窗: September 2010
This, the time for intubation, is measured immediately during the intubation, on the day that the specific patient participates in the study
次要结局
- time for preparing and cleaning the endoscopes(september 2010)
- number of intubation attempts(september 2010)
- success rate of endotracheal intubation(september 2010)
- total time for the intubation-procedure inclusive the time for distributing local analgesics(september 2010)
- Quality of the image from the videoscope(september 2010)
- Evaluation of the insertion cord of the flexible scope(september 2010)
- Evaluation of the working-/-injection-channel(september 2010)
研究者
Michael Seltz Kristensen
M.D.
Rigshospitalet, Denmark