Comparative Evaluation of Ambu AuraGain, LarySeal Pro LMA and I-gel in Pediatric Airway Management for Day-Case Surgery Under Controlled Ventilation: A Randomized Comparative Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Oropharyngeal Leak Pressure (OLP)
研究概览
简要总结
This study aims to compare the Ambu AuraGain, LarySeal Pro LMA, and i-gel regarding their insertion characteristics, ventilation efficacy, risk of gastric insufflation, fiberoptic view quality, intraoperative and postoperative airway-related complications, and hemodynamic stability.165 consecutive pediatric patients aged 2-9 years, weighing 10-30 kg, American Society of Anesthesiologists (ASA) physical status I or II, and scheduled for elective day-case surgery suitable for supraglottic airway device (SGAD) use.Patients will be randomly assigned (n= 55 per group) using a computer-generated random number sequence (www.random.org) to one of three groups:
- Group I: Ambu® AuraGain TM (Ambu Ltd Xiang Yu Xiamen, Fujian, China)
- Group II: LarySeal Pro® LMA (Flexicare Medical Limited, Cynon Valley Business Park, Mountain Ash, UK).Patients will receive oral midazolam before anesthesia, followed by standard monitoring, induction with sevoflurane, fentanyl, and atracurium, and insertion of an appropriately sized SGAD by experienced anesthesiologists. Ventilation quality, oropharyngeal leak pressure (OLP), peak airway pressure (Ppeak), fiberoptic glottic view, and gastric insufflation by ultrasound will be assessed. Anesthesia will be maintained with controlled ventilation and cuff pressure adjusted to 60 cmH₂O. At the end, neuromuscular blockade will be reversed, devices removed upon awakening, and patients observed for complications such as laryngospasm, Outcome parameter (s):
- Oropharyngeal Leak Pressure (OLP).
- Demographic and Clinical Data.
- Hemodynamics.
- Insertion Data.
- Peak Airway Pressure (Ppeak).
- Fiberoptic Glottic View Assessment.
- Ultrasound Assessment of Gastric Insufflation.
- Perioperative Complications.bronchospasm, or sore throat.
- Group III: I-gelTM (Intersurgical Ltd, Berkshire, RG41 2RZ, UK).
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
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age 2-9 years.
- •Weight 10-30 kg.
- •ASA Physical Status I or II.
- •Elective day-case surgery requiring general anesthesia with controlled ventilation using an SGAD.
- •Written informed consent from parent(s) or legal guardian(s).
排除标准
- •• ASA Physical Status III or IV.
- •Known or predicted difficult airway.
- •History of significant respiratory disease (e.g., asthma requiring frequent medication, active upper respiratory tract infection, reactive airway disease within the past month).
- •History of significant gastroesophageal reflux, hiatal hernia, BMI ≥ 35, or other conditions predisposing to increased aspiration risk.
- •Neuromuscular disorders affecting airway patency or respiratory function.
- •Known allergy or contraindication to study devices or anesthetic medications.
- •Participation in other clinical trials that could influence study outcomes.
研究组 & 干预措施
Group I: Ambu AuraGain LMA
supraglottic Airway device used for airway control
干预措施: supraglottic airway device (Device)
Group II: LarySeal Pro LMA
supraglottic airway device used for airway control
干预措施: supraglottic airway device (Device)
Group III: I-gel
supraglottic airway device used for airway control
干预措施: supraglottic airway device (Device)
结局指标
主要结局
Oropharyngeal Leak Pressure (OLP)
时间窗: from enrollment to the end of the study at 6 months
次要结局
- Peak Airway Pressure (P peak)(From enrollement to the end of the study at 6 months)
- Fiberoptic glottic airway view(From enrollment to the end of the study at 6 months)
- Ultrasound Assessment of Gastric Insufflation(From enrollement to the end of the study at 6 months)
研究者
Emad Mohamed Ahmed Abdelhafez
Lecturer of Anesthesia, Surgical Intensive Care and Pain Management
Kasr El Aini Hospital