Laryngeal Mask Airway I-Gel and Laryngeal Mask Airway Protector for Minor Urological Procedures Under General Anesthesia in Adult Patients: A Randomized Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Evaluation of the airway sealing pressure of the Laryngeal Mask Airway (LMA) in neutral, extended, and extended-rotated head positions
研究概览
简要总结
This will be a randomized comparative study comparing the two supraglottic devices i-gel and Protector, intraoperatively, during minor urological procedures under general anesthesia in adult patient.
详细描述
This randomized comparative study aims to evaluate the effectiveness, safety, and unwanted effects of two laryngeal mask airway devices, the iGel and the Protector. The study will involve adult patients during minor urological procedures under general anesthesia. Participants will be divided into two groups: in one group will be inserted the iGel laryngeal mask airway, while in the other group will be inserted the Protector laryngeal mask airway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients older than 18 years
- •Procedures in supine and lithotomy position
排除标准
- •Tumors or anatomical anomalies of the upper airway
- •Known history of difficult intubation
- •Limited mouth opening less than 2cm
- •Decreased compliance of the lungs or the thoracic cage
- •Need of mechanical ventilation after the surgery
研究组 & 干预措施
LMA igel group
干预措施: LMA igel (Device)
LMA protector group
干预措施: LMA protector (Device)
结局指标
主要结局
Evaluation of the airway sealing pressure of the Laryngeal Mask Airway (LMA) in neutral, extended, and extended-rotated head positions
时间窗: Leak pressure will be measured in cmH2O within 60 seconds after successful placement: first in the neutral position, second in the extended position, and third in the extended rotated head position
After the closure of the adjustable pressure limiting valve (APL) of the ventilation machine with a continuous fresh gas flow of 3L/min, a stethoscope for auscultation will be placed to the lateral position of the thyroid cartilage. Leak pressure is defined as the maximum airway pressure (Ppeak) during which no audible sound, like leak, is detected with the placement of the stethoscope at the thyroid cartilage. Successful placement of the laryngeal mask, will be confirmed right after insertion by the auscultation of both hemithoraces, the indication of capnography, and the ratio of inhaled to exhaled pulmonary volume
次要结局
- Success rate of each device for patients with a potential difficult airway according to the Simplified Airway Index(The patients airway will be evaluated 24 hours before surgery based on the Simplified Airway Index for a potential difficult intubation)
- Number of attempts to successfully place a nasogastric tube through the specially designed channels of the laryngeal mask(Each attempt, from the moment the clinician picks up the nasogastric tube, will have a time frame of 5 seconds. If the nasogastric tube is not placed within 5 seconds, the attempt will be considered a failure)
- The time required for successful placement of the device(Measured from the moment the clinician picks up the LMA device after induction of general anesthesia until the appearance of the first capnography waveform on the monitor with a maximum duration of 60 seconds per attempt and up to three attempts allowed)
- Documentation of adverse events after the exertion(Immediately after the exertion)
研究者
Nikolopoulou Maria Zozefin
Anesthesiology Resident at Sismanoglio General Hospital
Sismanoglio General Hospital