Gastric Insufflation Volume Using I-gel Versus Ambu AuraGain in Pediatric Patients Undergoing Elective Orthopedic Operations Under General Anesthesia: a Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Gastric antrum cross-sectional area (CSA)
研究概览
简要总结
Our study aimed to compare the gastric insufflation volume between Ambu AuraGain and i-gel and its relationship with the oropharyngeal sealing pressure and the incidence of postoperative complications in generally anesthetized controlled-ventilated pediatric patients undergoing elective orthopedic operations.
详细描述
Supraglottic Airway Devices (SADs) refer to a wide range of medical devices that can act as a passageway for oxygenation, ventilation, and administration of anesthetic gases and may be deemed an alternative to Endotracheal Tubes (ETTs).
Oropharyngeal sealing pressure (OLP) provides insight into the risk of gastric insufflation and aspiration risk. It is considered a measure of adequate performance and successful placement based on the premise that the SAD is sited properly in the hypopharynx after blind placements, and it is a useful comparator between SADs.
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
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 2 to 12 years.
- •Both sexes.
- •American Society of Anesthesiologists (ASA) physical status I and II.
- •Scheduled for elective orthopedic operations in a supine position under general anesthesia.
排除标准
- •Patients with a known history of gastro-oesophageal reflux disorders.
- •Full Stomach.
- •Anticipated difficult mask ventilation or intubation.
- •Body mass index "BMI" exceeding 20% of the ideal.
- •A history of chest problems.
- •History of the gastrointestinal tract or thoracic surgeries.
研究组 & 干预措施
Ambu Auragain group
Ambu Auragain was inserted after induction.
干预措施: Ambu Auragain (Device)
I-gel group
The I-gel device was inserted after induction.
干预措施: I-gel (Device)
结局指标
主要结局
Gastric antrum cross-sectional area (CSA)
时间窗: At the end of surgery before supraglottic airway devices removal (5 min)
Gastric antrum cross-sectional area (CSA) was measured before induction of general anesthesia, before supraglottic airway devices (SAD) insertion, after Ryle's tube insertion, and at the end of surgery before SAD removal.
次要结局
- Oropharyngeal leak pressure(Intraoperatively)
- Time of insertion of supraglottic airway devices(Intraoperatively)
- Number of attempts for insertion(Intraoperatively)
- Incidence of postoperative complications(24 hours postoperatively)
研究者
Aya Nabil Farahat
Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University