Comparison of EzVision® Videolaryngoscope and Gum Elastic Bougie-Assisted Machintosh Laryngoscopy in Patients Considering Difficult Intubation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Glottis viewing
研究概览
简要总结
The aim of this study is to compare the EzVision® videoryngoscope with conventional laryngoscopy using a Macintosh blade in patients with suspected difficult intubation. This study primarily aims to test the hypothesis that laryngoscopy image is better with EzVision® videoryngoscopy compared to direct laryngoscopy. The secondary hypothesis is also to test the view that, compared to direct laryngoscopy, EzVision® videolingoscopy will improve intubation success, reduce intubation attempts, shorten intubation time, facilitate intubation, and cause less additional complications such as bleeding or sore throat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 65 years old;
- •American Association of Anesthesiologists (ASA) physical condition I-II-III;
- •Elective surgery requiring oral endotracheal intubation for general anesthesia;
- •Compliance with one of the difficult intubation estimation criteria (if more than one)
- •Expected extubation in the operating room
排除标准
- •Refusal to participate in research;
- •Age <18 and >65
- •ASA IV and above
- •Emergency cases
- •Body Mass Index (BMI) > 40 kg/m
- •Cardiac surgery
- •Unexpectedly difficult intubation
研究组 & 干预措施
Patients to entubate with EzVision® videolaryngoscopy
Patients will intubate with EzVision® videolaryngoscopy
干预措施: EzVision® videolaryngoscopy (Device)
Patients to intubate with Macintosh blade
Patients will intubate with Macintosh blade
干预措施: Macintosh Blade (Device)
结局指标
主要结局
Glottis viewing
时间窗: Approximately 1 year
Glottical viewing will be measured by Modified Cormack Lehane grading. In this scoring system, number 1 indicates the best appearance, while number 4 indicates the worst situation where the glottis is not visible. This measurement have no specific value, but it evaluates glottis opening as visually. 1\. Fill view of the glottis 2a. Partial view of the glottis 2b. Arytenoids or posterior part of the vocal cords only visible 3. Only epiglottis visible 4. Neither glottis nor epiglottis visible
次要结局
- Intubation failure(Approximately 1 year)
- Attempted intubation(Approximately 1 year)
- Intubation time(Approximately 1 year)
- Ease of intubation(Approximately 1 year)
研究者
Mehmet Akif Yazar, MD
Principal Investigator
Nevsehir Public Hospital