The I-gel Plus Supraglottic Airway Device for Elective Surgical Procedures in Prone Position
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Leak fraction
研究概览
简要总结
I-gel Plus is a novel supraglottic airway device that has been evaluated in various studies with high success and low complication rates. Feasibility of supraglottic airway devices (SGA) in patients undergoing surgery in prone position has been demonstrated in some pilot studies and case series; however, the evidence is still limited. It is currently uncertain, if the i-gel Plus facilitates appropriate ventilation in individuals undergoing elective surgery in prone position.
The primary aim of this single-center non-inferior study is to assess the leak fraction of the i-gel Plus in patients undergoing surgery in prone position and to compare it with data from an existing prospective control cohort in patients undergoing surgery in supine position. Secondary aims are to investigate the oropharyngeal seal pressure and other secondary outcome parameters and to compare them with the control cohort.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduling for elective surgery in prone position
- •Planned airway management using a SGA
- •Adult patients (age 18-89 years)
- •ASA physical status 1-3
排除标准
- •Pregnant or breastfeeding women
- •Non-fasted patients
- •Increased risk of aspiration or other contraindications for supraglottic mask ventilation
- •Shared airway or intracavity open surgery
- •Body mass index (BMI) >35 kg/m2
- •Inability to understand or sign informed consent
结局指标
主要结局
Leak fraction
时间窗: 3 hours
Ventilation parameter - Leakage volume per tidal volume
次要结局
- Leakage volume (ml)(3 hours)
- Oropharyngeal seal pressure [cm H2O](3 hours)
- Minute ventilation (l/min/kg)(3 hours)
- Tidal volume (ml)(3 hours)
- Inspiratory peak pressure (cm H2O)(3 hours)
- Positive endexpiratory pressure (PEEP) (cm H2O)(3 hours)
- Respiratory rate (1/min)(3 hours)
- Endtidal CO2 [mmHg](3 hours)
- Number of insertion attempts(3 hours)
- Insertion success rate (%)(3 hours)
- First-attempt insertion success rate (%)(3 hours)
- Necessity of adjustment maneuvers during the procedure(3 hours)
- Insertion time (sec)(3 hours)
- Lowest oxygen saturation (%)(3 hours)
- Postoperative complications(24 hours postoperatively)
- Difficulty of insertion(3 hours)
- Ease of gastric tube insertion(3 hours)
- Complications at the end of surgery(3 hours)