Comparison of Gastric Insufflation Volume by Ultrasound Using I-gel and ProSeal Laryngeal Mask Airways in Patients Undergoing Urological Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Measurement of oropharyngeal leak pressure (OLP)
研究概览
简要总结
This study was planned to compare the gastric insufflation volume between i jel and ProSeal laryngeal mask airway (LMA) and its relationship with the oropharyngeal sealing pressure and the incidence of postoperative complications in patients undergoing urological surgery.
详细描述
Supraglottic airway devices (SADs) are widely used in both elective and emergency surgeries, resuscitation, and difficult airway management. Compared to endotracheal intubation, they are less invasive, require lower doses of anaesthetic agents, and cause less haemodynamic instability. Among supraglottic airway devices, the I-gel differs from other SADs in that it does not have an inflatable cuff; instead, it features a soft structure made of a transparent thermoplastic elastomer that mimics a cuff. In addition, it has a gastric channel alongside the airway tube that allows for gastric aspiration.
ProSeal LMA is one of the most commonly used SADs in clinical practice. It was developed in the early 2000s as a modification of the classic LMA and includes an inflatable cuff. Like the I-gel, it also features a gastric drainage channel for aspiration.
Aspiration pneumonia is a serious complication of anaesthesia, accounting for approximately 9% of all anaesthesia-related mortality. Traditionally, oropharyngeal leak pressure (OLP) provides information about the potential for gastric insufflation and thus the risk of gastric aspiration. Measurement of the gastric antral cross-sectional area (AGCA) by ultrasound allows for the estimation of gastric volume and helps assess the risk of aspiration.
This study was planned to compare the gastric insufflation volume between i jel and ProSeal LMA and its relationship with the oropharyngeal sealing pressure and the incidence of postoperative complications in patients undergoing urological surgery.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an ASA (American Society of Anesthesiologists) physical status score of 1 to 3
- •undergoing urological surgeries performed with I-gel or ProSeal LMA
排除标准
- •Difficult airway
- •Clinically significant upper respiratory tract infection
- •Pre-existing airway disease
- •Pre-existing airway disease
- •History of head and neck surgery
- •Pregnant patients
- •Patients with upper gastrointestinal tract disease
结局指标
主要结局
Measurement of oropharyngeal leak pressure (OLP)
时间窗: Five minutes after successful LMA placement
One minute after successful LMA placement and fixation, oropharyngeal leak pressure (OLP) will be measured by setting the adjustable pressure limiting valve (APL) to 40 mmHg and maintaining a fresh gas flow of 3 L/min. The OLP will be recorded as the pressure at which an audible leak sound is heard from the mouth.
次要结局
- Gastric volume(End of the operation, 5 minutes before LMA removal,)
- fiberoptic view grading(Five minutes after successful LMA placement)
- Complications during i jel and propseal LMA removal (emerge)(One minute after i jel and propseal LMA removal)
研究者
Zeynep Koc
principal investigator
Diskapi Yildirim Beyazit Education and Research Hospital