Prospective Randomized Trial Comparing the Performance of Two Supraglottic Airway Management Devices: I-Gel and Supreme LMA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Measure of the Airway Leak Pressure
研究概览
简要总结
This study will compare two supraglottic airway devices currently on the market. Supraglottic airway devices are used during general anesthesia to provide a patent airway. They are inserted blindly into the mouth once the patient has lost consciousness and they cover the laryngeal inlet. The I-Gel and the Supreme laryngeal mask airway (LMA) are the two devices to be compared. The I-Gel has no inflatable cuff, which makes it different from all other supraglottic airway devices currently in use. The Supreme shares some characteristics of the other LMA devices, but it is disposable. Our main goal will be to compare the airway leak pressure and the peak airway pressure of each devices. We will also measure the time needed for insertion, number of attempts needed to secure the airway and side effects related to the airway (cough, dysphagia, trauma, hoarseness of voice, sore throat).
详细描述
First of all, we will record the following demographic variables: age, sex, height, weight, BMI, surgery planned, American Society of Anesthesiology (ASA) status, dental state (good, bad, edentulous), tobacco use (none, ceased, active) and packs year, Mallampati score, thyromental distance and whether or not there is trauma on the tongue, teeth or lips prior to surgery.
Induction of anesthesia will be standardized with Fentanyl 1-3 mcg/kiloGram(kG) and Propofol 1-3,5 mg/kG. The use of myorelaxant will be mandatory, but either succinylcholine or rocuronium will be used as long as complete disappearance of T1 is observed before attempting supraglottic airway insertion.
Prior to insertion, ease of ventilation (yes/no) will be noted.
The two airway devices will be used according to manufacturers instructions. The sizes of the devices will be chosen according to weight:
I-Gel: 50-90 kG: #4 and 90 Kg and up: #5 LMA Supreme: 50-70 Kg: #4 and 70-100 Kg: #5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Weight more than 50 kg;
- •Body Mass Index less than 30;
- •ASA I to III.
排除标准
- •Symptomatic gastro oesophageal reflux disease (GERD);
- •Non fasted patients;
- •Nasogastric tube in place;
- •Intestinal obstruction;
- •Ear, nose and throat surgery in the past or deformation of the airway;
- •Known difficult airway (Cormack-Lehane grade 3-4);
- •Oral cavity opening less than 3 cm;
- •Pregnancy.
结局指标
主要结局
Measure of the Airway Leak Pressure
时间窗: After introduction of the supraglottic device before the beginning of the surgery.
次要结局
- Measure of the Peak Airway Pressure(After introduction of the SAD before the beginning of the surgery.)
- Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)(On the day following surgery)
- Time Needed to Secure the Airway(From opening of the mouth to thoracic expansion and presence of End Tidal CO2 up to five minutes.)
- Airway Manipulation and Blood on Device at Removal(During and after anesthesia when the device is removed.)
- Number of Participants With Successful Attempts to Introduce the Devices(At the beginning of anesthesia before the beginning of the surgery.)
研究者
Nikola Joly
MD
Maisonneuve-Rosemont Hospital