Comparison of Airway Sealing Pressure Between I-gel® and I-gel Plus® in Elderly Patients Under General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Airway Sealing Pressure
研究概览
简要总结
This study compares the airway sealing pressure between I-gel® and I-gel plus® in elderly patients (aged 65-85) undergoing general anesthesia. I-gel® is a supraglottic airway device with a non-inflatable cuff, and I-gel plus® is an improved version with a larger gastric drainage channel, enhanced airway tube, and longer cuff tip for better sealing. The study aims to evaluate differences in sealing pressure and other performance metrics in this population, where anatomical changes may affect device efficacy.
详细描述
Supraglottic airway devices (SGAs) are widely used as alternatives to endotracheal intubation in anesthesiology and emergency medicine. The I-gel® (Intersurgical Ltd., UK) features a non-inflatable cuff for ease of insertion and excellent sealing. The I-gel plus® improves on this with a larger gastric channel, better airway tube, and extended cuff tip to enhance sealing pressure.
Prior studies compared I-gel® to other SGAs like ProSeal or Supreme, showing variable sealing pressures, but direct comparisons between I-gel® and I-gel plus®, especially in elderly patients, are lacking. Elderly patients may experience upper airway anatomical changes affecting SGA performance. Higher sealing pressure is crucial for surgeries with increased intra-abdominal pressure (e.g., laparoscopic or robotic surgery) and can reduce respiratory complications in patients with airway hypersensitivity.
This prospective crossover study will quantitatively assess differences in sealing pressure, fixation stability, and other outcomes. Both devices are approved by the Korean MFDS and will be used within approved indications for academic evaluation of efficacy in elderly patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
No blinding is implemented.
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 65-85 years with ASA physical status I-III.
- •Scheduled for elective surgery under general anesthesia lasting less than 3 hours.
排除标准
- •High risk of aspiration (history of gastrectomy, BMI >35 kg/m², gastroesophageal reflux disease, hiatal hernia).
- •Poor dental status preventing I-gel fixation.
- •Cervical spine instability.
- •Anatomical abnormalities in mouth or larynx, or high risk of respiratory complications (asthma, COPD, recent pneumonia).
- •Pregnancy.
- •Other cases deemed inappropriate by the investigator.
研究组 & 干预措施
Group I
Patients receive I-gel® first, followed by removal and insertion of I-gel plus®.
干预措施: I-gel first (Device)
Group I
Patients receive I-gel® first, followed by removal and insertion of I-gel plus®.
干预措施: common (Behavioral)
Group P
Patients receive I-gel plus® first, followed by removal and insertion of I-gel®.
干预措施: common (Behavioral)
Group P
Patients receive I-gel plus® first, followed by removal and insertion of I-gel®.
干预措施: I-gel plus first (Device)
结局指标
主要结局
Airway Sealing Pressure
时间窗: During surgery, immediately after each device insertion
Comparison of sealing pressure (cm H2O) between I-gel® and I-gel plus®, measured after insertion with fresh gas flow at 3 L/min and valve closed.
次要结局
- Fixation Stability(During surgery)
- Time to Successful Insertion(During surgery)
- Ease of Insertion(During surgery)
- Operator Complications(Post-surgery up to 24 hours)
研究者
Hansu Bae
Assistant professor
Dongguk University International Hospital