Clinical Comparison Between Midline and Right-sided Insertion of the Videolaryngoscope for Intubation - a Randomized, Controlled, Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 4
- 主要终点
- Comack-Lehane Classification
研究概览
简要总结
The videolaryngoscope is an established tool for securing the airway, even in difficult situations. It remains unclear which insertion technique is the safest and fastest in the difficult airway.
详细描述
Videolaryngoscopy is one of the standard methods of airway management in the Department of Anesthesiology with Surgical Intensive Care, is anchored in the applicable Standard Operating Procedures (SOP) and is used in everyday clinical practice.
In order to establish the above-mentioned generality, the patients are divided into 2 groups. In the preoperative visit, the patients are divided into easy and difficult airway, and a randomization regarding the induction technique is done paper-based after induction of anesthesia.
Patients* identified in the preoperative visit with a risk for difficult intubation or difficult laryngoscopy (Mallampati ≥ 3, thyromental distance below 6.5cm, sternomental distance below 12.5cm, conversion from conventional laryngoscopy to VLS in the history, cervical spine immobilization, lack of possibility for reclination) are randomized into one of the two groups:
Group DR (difficult right) corresponds here to the right-sided insertion technique in the difficult airway.
Group DM (difficult middle) corresponds to the middle access route in the difficult airway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Computer generated randomisation, Patient under general anaesthesia during procedure
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective surgery under general anesthesia with indication for airway protection via endotracheal intubation
- •age ≥ 18 years
- •indication for primary videolaryngoscopic Intubation (VLS) and/or at least one of the following criteria:
- •Mallampati ≥ 3
- •Thyromental distance <6.5cm
- •Sternalomental distance <12.5 cm
- •Conversion from conventional laryngoscopy to VLS in history
- •Cervical spine immobilization/lack of ability to recline.
排除标准
- •Pregnant patients
- •Participation in another prospective clinical intervention study within the last 30 days and during participation in this study
- •Necessary Rapid Sequence Induction
- •Indications of impossible mask ventilation and/or videolaryngoscopy (mouth opening < 3.5 cm, ...)
- •Existence of tracheal cannula prior to operation
结局指标
主要结局
Comack-Lehane Classification
时间窗: immediately after the intervention
Laryngeal vision is determined by Cormack/Lehane classification (C/L)
次要结局
- Time to laryngeal view(immediately after the intervention)
- Complications during induction(15 minutes)
- Time to intubate(immediately after the intervention)
- First pass success(immediately after the intervention)
- Complication on first postoperative day(24 hours)
研究者
Sascha Treskatsch
Prof. Dr. med.
Charite University, Berlin, Germany