Vie Scope Versus Macintosh Laryngoscope in Expected Easy Airways: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- Rate of Successful Intubation With One Attempt
研究概览
简要总结
The rate of successful intubation and the required time for intubation, using Vie Scope and Macintosh Laryngoscope will be compared, in order to evaluate the efficacy of Vie Scope in comparison with Macintosh in expected easy airways. Hence, a prospective randomized controlled single-blind superiority clinical trial will be conducted.
Inclusion criteria: patients of both sexes, positive or negative rapid test for COVID-19 or possible contamination, age ≥18 years old, BMI: 18.5 - 30 kg/m2, visualization of the glottis grade 1 or 2, according to Cormack-Lehane Classification.
Exclusion criteria: age under 18 years old, BMI under 18.5 kg/m2 and BMI over 30 kg/m2, visualization of the glottis grade 3 - 4, according to Cormack-Lehane Classification.
The laryngoscopy and intubation of the patients will be attempted by the same person-resident of Anesthesiology, under the supervision of experienced Anesthesiologist consultants.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of both sexes
- •Positive or negative rapid test for COVID-19 or possible contamination
- •Age ≥18 years old
- •BMI: 18.5 - 30 kg/m2
- •Visualization of the glottis grade 1 or 2, according to Cormack-Lehane Classification.
排除标准
- •Age under 18 years old
- •BMI under 18.5 kg/m2 and BMI over 30 kg/m2
- •Visualization of the glottis grade 3 - 4, according to Cormack-Lehane Classification.
结局指标
主要结局
Rate of Successful Intubation With One Attempt
时间窗: Evaluation immediately after the first attempt of intubation
This outcome depends on whether the intubation of each patient will be successful or not, after the first attempt of intubation
Mean Intubation Time
时间窗: Assessment of the required mean time interval for intubation, immediately after the insertion of laryngoscope's blade into the patient's mouth
Mean time interval required for intubation, which is determined from the time of the insertion of the laryngoscope into the patient's mouth until the time of the inflation of the tube's cuff on each patient
次要结局
- Rate of Successful Intubation(Evaluation immediately after the intubation attempts)
- Visualization of the Glottis, According to Cormack Lehane Classification(This outcome will be evaluated during laryngoscopy and intubation of each patient)
研究者
Vasileios Boviatsis
Principal Investigator
St. Andrew's General Hospital, Patras, Greece