Comparison of the Ambu AuraGain vs. LMA Supreme in Paralysed Patients Undergoing Gynecologic Laparoscopic Surgery in the Trendelemburg Position
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Airway seal pressure
研究概览
简要总结
The aim of the study is to compare the performance of two supraglottic airway devices (SGA), the new Ambu AuraGain and the LMA Supreme, in sixty female patients undergoing gynaecologic laparoscopy in the trendelemburg position.
Primary outcome is the airway seal pressure. Secondary outcomes are ease of insertion, quality of ventilation, endoscopic view of the glottis, gastric tube passage and complications.
详细描述
The patients are randomly assigned to 2 groups:
- Group 1: Ambu AuraGain.
- Group 2: LMA Supreme, Teleflex
Procedure:
The investigation protocol contains the following sections:
- Induction of anaesthesia. Intravenous infusion of remifentanil and propofol targeting the effect site (2-4 ng/ml and 4-6 µg/ml respectively). No muscle relaxant will be used for insertion of the SGA. Rocuronium 0.2 mg/Kg will be administered before initiation of pneumoperitoneum.
- Insertion of the SGAs. The size of the SGA device used is based on the manufacturers' recommendations. All devices are deflated a lubricated prior to use. Once inserted, the cuff is be inflated with a manometer up to 60 cm H20 Position of the device is adjusted if needed. Data recorded: size of SGA, time an number of attempts.
- Fibreoptic evaluation of the SGAs anatomical position: complete view of the vocal cords (I), epiglottis visible inside, but not causing obstruction (II), epiglottis visible and obstructing the glottic inlet (III), or glottic structures not identified (IV).
- Functionality of the gastric drainage channel of the SGAs: passage of a 16 G size tube.
- Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and at 15, 30 and 60 minutes. The maximum pressure allowed is 40 cm H2O.
- Ventilatory mechanics and parameters are measured at baseline, and at 15, 30 and 60 minutes.
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients evaluated as eligible for a SGA
- •ASA I-III
- •Without criteria for difficult airway
- •Body Mass Index ≤ 35 kg/m2
- •The patient has signed the Informed Consent
- •The patient understands his or hers rights and consequences related to this investigation
排除标准
- •Planned operation time > 2 hours
- •High risk of regurgitation
- •Respiratory tract pathology
- •Preoperative sore throat
- •Patients with a known or predicted difficult airway
- •Patients diagnosed with dementia or any mental handicaps
- •Patient who has a guardian.
研究组 & 干预措施
Ambu AuraGain
Insertion of the supraglottic device and evaluation of its clinical performance
干预措施: Ambu AuraGain evaluation (Device)
Ambu AuraGain
Insertion of the supraglottic device and evaluation of its clinical performance
干预措施: Laparoscopic surgery (Procedure)
LMA Supreme
Insertion of the supraglottic device and evaluation of its clinical performance
干预措施: LMA Supreme evaluation (Device)
LMA Supreme
Insertion of the supraglottic device and evaluation of its clinical performance
干预措施: Laparoscopic surgery (Procedure)
结局指标
主要结局
Airway seal pressure
时间窗: At 15 minutes
Maximum airway pressure that the device can achieve without oropharyngeal leak of gas.
次要结局
- Endoscopic view of glottic structures(At 15 minutes)
- Ease of insertion of the device(Baseline)
- Change in Quality of ventilation(At baseline and at 15, 30 and 60 minutes)
- Gastric tube insertion(At 5 minutes)
- Incidence of perioperative complications(2 hours)
研究者
Ana M Lopez
MD, PhD
Hospital Clinic of Barcelona