Comparison of Airway Performance Between I-gel and SaCoVLM in Patients Undergoing Elective Laparoscopic Cholecystectomy: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Oropharyngeal Leak Pressure (OLP)
研究概览
简要总结
This prospective observational study aims to compare the ventilation performance and safety of the i-gel and SaCoVLM supraglottic airway devices in adult patients undergoing elective laparoscopic cholecystectomy. Ventilation-related parameters, airway sealing performance, insertion characteristics, and perioperative complications will be evaluated.
详细描述
Laparoscopic surgery requires the creation of pneumoperitoneum and frequently involves patient positioning changes, both of which can increase intrathoracic and airway pressures. These physiological changes may affect the performance of supraglottic airway devices and challenge effective ventilation.
Second-generation supraglottic airway devices are increasingly used as alternatives to endotracheal intubation in laparoscopic procedures because they provide effective ventilation while reducing airway-related complications. The i-gel is widely used due to its ease of insertion, integrated gastric drainage channel, and favorable safety profile. The SaCoVLM (Video Laryngeal Mask) is a novel supraglottic airway device that enables direct visualization of laryngeal structures during placement, allowing confirmation of optimal positioning and potentially improving airway management.
This prospective observational study will compare the i-gel and SaCoVLM in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Ventilation performance, airway sealing pressure, insertion success, ease of placement, hemodynamic responses, and perioperative airway-related complications will be assessed. The findings may provide further evidence regarding the clinical performance and safety of these devices during laparoscopic surgery.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years.
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Patients scheduled for elective laparoscopic cholecystectomy.
- •Patients undergoing general anesthesia.
- •Patients who provide written informed consent.
排除标准
- 未提供
研究组 & 干预措施
Group I: i-gel group
Patients receiving airway management with the i-gel supraglottic airway device
Grup II: SaCoVLM
Patients receiving airway management with the SaCoVLM supraglottic airway device
结局指标
主要结局
Oropharyngeal Leak Pressure (OLP)
时间窗: After device insertion and after pneumoperitoneum creation during surgery.
Oropharyngeal leak pressure (OLP) will be measured and compared between the i-gel and SaCoVLM groups to evaluate airway sealing performance during elective laparoscopic cholecystectomy..
次要结局
- First-Attempt Insertion Success Rate(During device insertion procedure)
- Device Insertion Time(During device insertion procedure)
- Gastric Tube Insertion Success Rate(Immediately following successful placement of the supraglottic airway device before initiation of mechanical ventilation)
- Peak Airway Pressure (PAP)(5 minutes after pneumoperitoneum is established.)
- End-Tidal Carbon Dioxide (EtCO₂)(Throughout laparoscopic surgery.)
- Postoperative Sore Throat(Within 24 hours after surgery.)
- Hoarseness(Within 24 hours after surgery.)
- Blood Staining and Mucosal Trauma(Immediately after device removal.)
- Hemodynamic Parameters(Baseline, immediately after device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery.)