NCT03760679招募中不适用
Comparison of Laryngeal Mask Supreme and I-Gel in Edentulate Geriatric Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Change in Airway Seal Pressure Values
研究概览
简要总结
The primary aim of this study is to evaluate ease and duration of placing Laryngeal Mask Supreme (LM) and applying I-gel in geriatric patients without teeth. The secondary aim is to compare their effects on ventilation parameters.
详细描述
Prospective, randomized and double-blind study, aged from 18 to 65 years undergoing elective laparoscopic gynecological surgery.
The patients are randomly assigned to 2 groups:
- Group 1: i-gel
- Group 2: laryngeal mask airway - Supreme
Procedure:
The investigation protocol contains the following sections:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists Classification I-III patients
- •patients aged 65 years and older
排除标准
- •having teeth or fixed prosthesis
- •having a pathology of the neck or the upper respiratory tract
- •having a risk of regurgitation of gastric content/ aspiration (prior upper gastrointestinal system surgery, hiatus hernia, gastrointestinal reflux, history of peptic ulcer and full stomach)
- •history or possibility of difficult airway (history of impossible intubation, mallampati score of 3-4, sternomental distance of shorter than 12 cm, thyromental distance of shorter than 6cm, head extension of lower than 90 degrees and mouth opening of lower than 1.5 cm)
- •lower pulmonary compliance or higher airway resistance (morbid obesity -BMI>35kg/m2- and pulmonary disease) Each patient will be examined preoperatively and American Society of Anesthesiologists Classification scores and mallampati scores will be recorded. Standard monitoring (ECG, pulse oximetry and noninvasive blood pressure measurement) and bispectral index monitoring will be performed in each patient before induction of anesthesia in the surgical room.
结局指标
主要结局
Change in Airway Seal Pressure Values
时间窗: intraoperative
insertion time
时间窗: intraoperative
placement of airway device (second)
次要结局
- dysphonia(postoperative 1th hour and 24th hour)
- sore throat(postoperative 1th hour and 24th hour)
- dysphagia(postoperative 1th hour and 24th hour)
研究者
Sule Ozbilgin
Investigator
Dokuz Eylul University
研究点 (2)
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