NCT01124825撤回4 期
Use of New Supraglottic Airway Devices in Severely Obese Patients: A Feasibility Study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Airway Sealing Pressure
研究概览
简要总结
The purpose of this study is to determine whether two new airway devices used during anesthesia called iGEL™ and KING-LTS-DTM work well and are safe in obese patients. They both work well in thin patients, but have not been tested in obese patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for elective surgery with an estimated duration of 30 to 120 minutes
- •American Society of Anesthesiologists (ASA) status I-III
- •Aged 18 to 65 years.
- •Body mass index (BMI) ≥ 35 kg/m2
排除标准
- •A history of difficult intubation;
- •Immobilized cervical spine;
- •Oxygen saturation less than 95% at room air;
- •A history of uncontrolled gastroesophageal reflux or hiatus hernia;
- •A history of ulcer surgery including vagotomy;
- •Previous gastric bypass surgery;
- •Diabetic gastroparesis;
- •Patients with known coagulation disorders (e.g. hemophilias, von Willebrand disease, factor V leiden diseases) or on systemic anticoagulation drugs (e.g. continuous heparin infusion); Patients with abnormal coagulation tests will be also excluded. However, asymptomatic patients will not be tested on any coagulation disorders.
- •Any pathologies of the mouth, pharynx or larynx, the access to the airway is restricted, or a difficult tracheal intubation is anticipated.
- •Pregnant or breast-feeding (pregnancy status will be confirmed by a pregnancy test, as it is standard for all surgical procedures at the University hospital).
结局指标
主要结局
Airway Sealing Pressure
时间窗: 1-3 hours
Oropharyngeal leak pressure in cm H2O for the duration of the case at 1, 15, 30, 60, 120 minutes.
次要结局
- Difference in insertion time for one of the supraglottic airway devices(1-3 hours)
研究者
研究点 (2)
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