Comparison of LMA® Gastro Airway and Gastro-Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography: a Prospective Randomized Observational Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Oropharyngeal leak pressure
研究概览
简要总结
Comparison of second generation supraglottic airway devices about anesthesiologist, endoscopist and patient, which used for gastrointestinal procedures. The investigators believe that the endoscope will be easier to reach by the part of GLT extending to the esophagus, but the structural stiffness of this part may damage the esophageal mucosa. On the other hand, since the endoscopic canal of the LMA® Gastro ends at the upper end of the esophagus, it may be more difficult to orient the endoscope to the esophagus, but it may be superior in terms of ventilation efficiency. Therefore these two device worth for comparing.
详细描述
Supraglottic airway (SGA) devices are produced for avoiding endotracheal intubation for anesthesic interventions. Second generation SGA's like GLT and LMA® Gastro airway are using for endoscopic biliopancreatic procedures. Both of them have an airway canal and endoscopic canal. Although they can use for same reason, their designs are different. So, their airway securities, endoscopic manipulations and complications, would be different.
This study planned as single blind. American Society of Anesthesiologists (ASA) Physical status 1-2 100 patients which will be take endoscopic retrograde cholangiopancreatography (ERCP) included. The study starts after randomization and ends after discharge from the recovery room. All patients will be monitorised for hemodynamic parameters. Depth of anesthesia will be provided by bispectral index (BIS) monitoring. After anesthesia induction SGA will placed by an experienced anesthesiologist. Bilateral chest movements and auscultation, capnogram graphy and oropharyngeal leak pressure test will be used for confirmation of placement. After procedure endoscopist will take pictures of esophagus and hypopharynx. After extubation and sufficient consciousness and breathing of patient, patients will be transferred to post-anaesthesia care unit (PACU). Vital parameters will continue to monitoring in PACU. Patients will be discharge as usual with an Aldrete score ≥ 9.
Data will be collected during the procedure and in recovery room. Data will be stored in electronic database without mention to patient's name.
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)
盲法说明
closed envelope.technique
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
- 否
入选标准
- •ASA Physical Status 1-2
- •Elective Procedures
- •Weight 50-100 Kg
排除标准
- •Laryngeal mask airway contraindications.
- •Anesthesic drug allergies
- •Height <155 cm
- •Body Mass index > 35 kg/m2
- •Alcohol or narcotic drug usage
- •Restrictive or obstructive pulmonary diseases
- •Hepatic cardiac or renal failure
- •Psychotic problems
- •Neurologic or cognitive deficiencies.
- •Pregnancy
- •Difficult airway or facial deformities
- •Previous cervical surgery or cervical radiotherapy
- •Previous esophagus surgery
- •High risk of pulmonary aspiration
结局指标
主要结局
Oropharyngeal leak pressure
时间窗: Intra-operative; after device insertion
Oropharyngeal leak pressure is the airway pressure at which the circuit pressure stabilizes by closing the expiratory valve of the circle system at a constant gas flow of 3 L / min.
Endoscopist satisfaction analysis: score
时间窗: Immediately after the procedure
Endoscopist will score from 0 (worst) to 10 (best)
Leakage rate percentages
时间窗: Intra-operative; after device insertion at first minute
The leakage rate percentage is the calculation of the difference between the adjusted tidal volume and the exhaled tidal volume and then proportioning to the adjusted tidal volume.
次要结局
- Hypopharyngeal/Esophageal Mucosal status(Within the first minute after the procedure is completed, while the duodenoscope is being removed while it passes through the esophagus and hypopharynx)
- Blood staining on the device(Immediately after removing the supraglottic airway device)
- Presence of sore throat(One hour after extubation)
研究者
Harun UYSAL
Anesthesiology And Reanimation Specialist
Bezmialem Vakif University