The New Third Generation Video Laryngeal Mask Evaluation: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- First insertion attempt success rate
研究概览
简要总结
The goal of this study is to evaluate the performance of the new video laryngeal masks for securing airway in patients undergoing general anaesthesia. Main goal is to evaluate the first insertion attempt success rate, time to adequate ventilation, sealing pressures and adverse events.
详细描述
First, informed consent for study participation will be obtained from the patient. The consent will be collected during the preoperative evaluation by the anesthesiologist responsible for providing anesthesia care during the surgical procedure, in the preoperative holding area.
After obtaining informed consent, a routine preoperative assessment will be conducted by the anesthesiologist, including standard preparation procedures (e.g., establishing peripheral venous access, evaluation of airway management risk, etc.). Randomization will be performed using a computerized online tool (studyrandomizer.com).
The patient will then be transferred to the operating room, where standard monitoring will be initiated in accordance with the principles of safe anesthesia care.
Induction of anesthesia will follow, during which propofol and sufentanil will be administered in doses determined by the attending anesthesiologist. A muscle relaxant will not be used to facilitate insertion of the laryngeal mask airway (LMA). Once an adequate depth of anesthesia is achieved-defined by an entropy value of SE < 60-airway management will proceed according to the patient's assigned group (Group A - SaCoVLM; Group B - Supreme).
In both groups, the back of the LMA will be lubricated with a water-based gel. Group A will receive airway management using the SaCoVLM™ video laryngeal mask. Group B will receive airway management using the Supreme™ laryngeal mask.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient without predicted difficult airway (MACOCHA score ≤ 2), undergoing a planned surgical procedure under general anesthesia with an indication for airway management using a laryngeal mask.
- •Patient aged 18 years or older.
排除标准
- •Patient younger than 18 years.
- •Patient with predicted difficult airway (MACOCHA score > 2).
- •Patient with a history of difficult airway.
- •Patient requiring airway management with a method other than a laryngeal mask.
- •Refusal or failure to sign the informed consent for study participation.
- •Patient undergoing emergency surgery.
- •Administration of muscle relaxants for LMA insertion.
- •State Entropy value below 30 during LMA insertion.
- •State Entropy value above 60 during LMA insertion.
研究组 & 干预措施
SaCo VLM laryngeal mask
In this group the video laryngeal mask is used for securing airway.
结局指标
主要结局
First insertion attempt success rate
时间窗: From the start of the attempt to the end of the general anesthesia.
First insertion attempt success rate. Successful attempt is considered if adequate ventilation is reached immediately after insertion without the need for realignment.
次要结局
- Time to adequate ventilation(From the initiation of the first insertion attempt until the end of general anesthesia.)
- Sealing pressure(From adequate ventilation until removing of the laryngeal mask.)
研究者
Michal Kalina
Deputy of medical director
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.