A Comparative Study Between Laryseal Pro Supra Glottic Device (SGD) With Proseal Laryngeal Mask Airway Regarding Clinical Performance in Patients Undergoing Ophthalmic Surgery. A Prospective Randomized Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- The time of insertion of supra glottic device
研究概览
简要总结
Difficult airway is a nightmare to every anesthetist. Over the last decade, several supraglottic airway devices appeared in the clinical field as an alternative to the more invasive endotracheal intubation(1). However, many anesthetists found themselves unaccustomed with the newly invented devices .Supraglottic airway devices (SAD) have become valuable for both routine and difficult airway management. After the creation of the laryngeal mask airway (LMA) classic in the 1980s, there has been a steady increase in the applications for use of supraglottic airways. Developed by Dr. Archie Brain in 2000, the ProSeal laryngeal mask airway (P-LMA) is a second-generation supraglottic airway device (SAD) with two lumens separating the alimentary and respiratory channels from each other This study aim to compare the use of the Laryseal Pro and the Proseal LMA as a supraglottic devices by measuring the time of insertion (which is defined as time interval in seconds between removing the ventilation mask and picking the device up till connecting to the ventilator and appearance of the first wave on the capnogram)
Objectives:
To determine ease of insertion for each supra glotic device. To Estimate the time needed for insertion for each supra glotic device. To identify airway pressure leakage, gastric tube insertion success and complication for each device.
It is hypothesized that the Laryseal pro is a safe superior supraglottic airway device and its insertion is easier than the LMA-Proseal .
详细描述
This a randomized control trial is designed to include (120) patients ASA physical status I ,II patients ranging from(18) to(60)years old scheduled for ophthalmic surgery
Patients meeting the inclusion criteria will be randomly assigned to receive either:
Group A: Laryseal pro supra glottic device (SGD) (n=60) Group B: Laryngeal Mask Airway- Proseal™ (n=60) Anesthesia management
Preoperative procedures:
After being accepted into the study, participants age, gender, weight, medications and any other co morbidities will be collected. patients will be allowed to fast for 6-8 h before surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization will be done by computer generated numbers and concealed by serially numbered, opaque and sealed envelopes. The details of the series will be unknown to the investigators and the group assignment will be kept in asset of sealed envelopes each bearing only the case number on the outside.
This study will be performed by 2 investigators; the first one (implementing doctor) who will insert supra glottic airway device based on patients' weight as per the manufacturers' size recommendations and according to a computer-generated sequence of random numbers and sealed envelope. The second anesthetists (planning doctor) will be blinded to the technique performed, and will monitor the patients intra and postoperatively.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both males and females
- •Age 18-60 years
- •GANZOURI airway scores less than 4
- •Patients undergoing ophthalmic surgeries not exceeding two hours under general anesthesia (cataract surgery,glaucoma surgery, corneal transplant, strabismus surgery
排除标准
- •Patients have risks of gastric aspiration (patients known to have gastro esophageal reflux disease (GERD), hiatus hernia or previous upper gastrointestinal tract surgery)
- •patients have respiratory or pharyngeal pathology
- •morbidly obese patients with body mass index >40 kg/m3
结局指标
主要结局
The time of insertion of supra glottic device
时间窗: time interval between picking the device up till appearance of the first wave on the capnogram. (seconds)
time interval between picking the device up till appearance of the first wave on the capnogram
次要结局
- complications(it will be measured postoperatively at 0, 3, 6 hours)
研究者
Ahmed nabih youssef
Lecturer of anesthesia
Kasr El Aini Hospital