Prospective Randomized Comparison Between a Fiber Optic Intubation Via the Ambu® AuraGain ™ or the i-Gel® Laryngeal Mask Until a Complete Airway Protection in Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Time of successful intubation
研究概览
简要总结
The aim of this study is the randomized comparison of two laryngeal mask (Intersurgical i-gel® and Ambu®AuraGain™) in obese patients
详细描述
Since the incidence of a difficult intubation lies between 4.5% -7.5%, the search for alternative airway devices has been forced in the past.
As an option, the laryngeal mask is suitable, which has been used as a universal airway with a high degree of safety in routine anesthesia.
There are numbers of different laryngeal masks available which have the characteristic to insert an endotracheal tube through the ventilation lumen.
The indications for these laryngeal masks can be extended due to continuous improvements in the laryngeal masks, these laryngeal masks can also be used in obese patients. Obese patients generally have a 4-fold increased risk of a difficult airway, and a BMI over 35 is a predictor of a difficult tracheal intubation.
There are no studies comparing the Intersurgical i-gel® Laryngeal Mask and the Ambu®AuraGain ™ Laryngeal Mask 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
- Treatment
- 盲法
- Single (Participant)
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
- 是
入选标准
- •Shoulder-/Elbow-/Hip-/Knee- or Foot - Surgery
- •Signed informed consent
- •BMI > 35kg/m2
排除标准
- •Non-sober patients (last meal <6 h)
- •Symptomatic reflux disease
- •Hiatus hernia
- •Significant cardiovascular risk factors
- •Severe COPD
- •Gastric band or gastric bypass
- •Disease which allows an accurate examination of the physicians (e.g. neuromuscular, mental, metabolic disease)
- •Drug or drug abuse in the recent past
- •Legal immaturity (incompetence)
- •Acute disease, which calls into question the narcotic potential
- •Patients with whom the use of a laryngeal mask is contraindicated or otherwise not possible
研究组 & 干预措施
Ambu® AuraGain™
Intervention with Ambu® AuraGain™Laryngeal Mask
干预措施: Ambu AuraGain (Device)
Intersurgical i-gel®
Intervention with Intersurgical i-gel® Laryngeal Mask
干预措施: Intersurgical i-gel (Device)
结局指标
主要结局
Time of successful intubation
时间窗: intraoperative
Measurement of a fiberoptic intubation with the laryngeal mask. Start: Insertion of the fiberoptic into the larynxmask until the intubation has been done and after the fiberoptic has been removed.
次要结局
- Number of Insertions (of the laryngeal mask)(intraoperative)
- Time of insertion(intraoperative)
- Number of insertion attempts(intraoperative)
- Gastric volume(intraoperative)
- Oropharyngeal leak pressure of the Ambu®AuraGain ™(intraoperative)
- Oropharyngeal leak pressure of the Intersurgical i-gel®(intraoperative)
- Measurement CO2 (kPa):(intraoperative)
- Reasons for the unsuccessful intubation(intraoperative)
- Number of esophageal intubations(intraoperative)
- Resistance (for an EET):(intraoperative)
- Location of the mask (Brimacombe)(intraoperative)
- Swallowing (no / little / medium / strong)(5hour postoperative)
- Positioning of the gastric probe(intraoperative)
- Successful Ventilation(intraoperative)
- Measurement of heart rate(intraoperative)
- Measurement of blood pressure(intraoperative)
- Measurement of oxygen saturation(intraoperative)
- Maximum ventilation pressure(intraoperative)
- Number of intubation attempts(intraoperative)
- Hoarseness (no / little / medium / strong)(5hour postoperative)
- Blood on laryngeal mask after intubation(intraoperative)
- Throat pain (no / little / medium / strong)(5hour postoperative)
研究者
Berthold Moser
Principal Investigator
Schulthess Klinik