Evaluation of SaCoVLM™ Video Laryngeal Mask Airway for Airway Management by Inexperienced Military Medics: A Two-Phase Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- First-Attempt Success Rate of SaCoVLM™ Insertion
研究概览
简要总结
A prospective, two-phase interventional study evaluating the performance, safety, and usability of the SaCoVLM™ video laryngeal mask airway for airway management by military medics with limited intubation experience. The study includes simulation-based training and clinical application in sedated patients undergoing elective surgery.
详细描述
This prospective, two-phase study evaluates the use of the SaCoVLM™ video laryngeal mask airway by military medics with limited airway experience. Phase 1 involves simulated intubation on manikins to assess device placement, visualization quality, and intubation success. Phase 2 evaluates clinical performance in adult patients undergoing elective surgery under general anesthesia. Key outcomes include first-attempt success rates, insertion and intubation times, glottic visualization scores, and complication rates. The study aims to determine whether SaCoVLM™ can enable safe and effective airway management in resource-limited and prehospital military settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Elective surgery
- •need for airway management
排除标准
- •Pregnancy
- •known airway abnormalities
- •allergy to anesthetics
研究组 & 干预措施
Simulation and Clinical Phase
Simulation-based and clinical use of SaCoVLM™ for airway management and intubation.
干预措施: SaCoVLM™ Video Laryngeal Mask (Device)
结局指标
主要结局
First-Attempt Success Rate of SaCoVLM™ Insertion
时间窗: Within 10 minutes of airway intervention.
Proportion of cases in which the SaCoVLM™ is successfully inserted on the first attempt during both simulated and clinical phases.
First-Attempt Success Rate of Orotracheal Intubation via SaCoVLM™
时间窗: Within 10 minutes following SaCoVLM™ placement.
Proportion of successful orotracheal intubations on the first attempt using the SaCoVLM™ device as a conduit.
次要结局
- Time to SaCoVLM™ Insertion(During initial airway management (simulation or clinical setting).)
- Time to Successful Intubation(During initial airway management (simulation or clinical setting).)
- Glottic Visualization Score(Immediately after SaCoVLM™ placement.)
- Subjective Difficulty Score(Immediately after each procedure.)
- Incidence of Airway Complications(From initiation of airway management to induction of general anesthesia (clinical phase only).)
研究者
Michal Soták
Principal Investigator
Charles University, Czech Republic