Evaluation of i-Gel and Air-Q sp3G Supraglottic Airway Device Placement by Fiberoptic Bronchoscopy and Comparison of Gastric Insufflation Volumes Using Ultrasound in Pediatric Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Correct SGA Placement Rate via Fiberoptic Bronchoscopy
研究概览
简要总结
This single-center, prospective, randomized controlled study aims to compare the placement accuracy of iGel and Air-Q sp3G supraglottic airway (SGA) devices in pediatric patients aged 1-8 years undergoing elective surgery under general anesthesia. Placement will be confirmed via fiberoptic bronchoscopy, and gastric insufflation will be assessed using ultrasound measurement of gastric antral cross-sectional area pre- and post-device placement. Secondary outcomes include postoperative complications such as sore throat, hoarseness and dysphagia.
详细描述
This single-center, prospective, randomized controlled trial will be conducted in pediatric patients aged 1-8 years undergoing elective pediatric or urological surgery under general anesthesia. Participants will be randomized into two groups to receive either an iGel or an Air-Q sp3G device. Device placement will be confirmed intraoperatively via fiberoptic bronchoscopy using a standardized grading system and gastric antral cross-sectional area will be measured with ultrasound before device insertion, immediately after insertion and at the end of surgery to evaluate gastric insufflation.
Secondary outcomes will include postoperative complications such as sore throat, hoarseness, dysphagia, mucosal bleeding, cough, laryngospasm, bronchospasm, nausea, vomiting and stridor. Intraoperative variables such as number of insertion attempts, ease of placement and peak airway pressure will also be recorded. The results are expected to identify which device offers better placement accuracy and lower gastric insufflation rates, thereby improving perioperative safety and postoperative recovery in pediatric patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 1-8 years
- •ASA I-III
- •Elective pediatric or urological surgery under general anesthesia with SGA use
- •Informed consent obtained from parents/guardians
排除标准
- •Parental refusal or inability to consent
- •ASA > III
- •Recent or current upper respiratory tract infection
- •History of difficult airway
- •Increased aspiration risk
- •Urgent/emergency surgery or non-fasted patients
- •Known allergy or contraindication to anesthetic agents
- •Severe asthma (attack within last 6 months)
- •Structural airway anomalies
- •Gastrointestinal pathology affecting stomach emptying
- •Previous stomach surgery
研究组 & 干预措施
igel
Pediatric patients aged 1-8 years undergoing elective pediatric or urological surgery under general anesthesia. Supraglottic airway (SGA) management will be performed using the igel second-generation device. Position verification will be performed via fiberoptic bronchoscopy (Grade 3-4 accepted as correct). Gastric volume will be measured with USG pre-insertion, post-insertion, and at surgery completion. Pre-, intra-, and postoperative complications will be documented as in the iGel group.
Air-Q sp3G
Pediatric patients aged 1-8 years undergoing elective pediatric or urological surgery under general anesthesia. Supraglottic airway (SGA) management will be performed using the Air-Q sp3G second-generation device. Position verification will be performed via fiberoptic bronchoscopy (Grade 3-4 accepted as correct). Gastric volume will be measured with USG pre-insertion, post-insertion, and at surgery completion. Pre-, intra-, and postoperative complications will be documented as in the iGel group.
结局指标
主要结局
Correct SGA Placement Rate via Fiberoptic Bronchoscopy
时间窗: Device placement will be assessed intraoperatively
In pediatric patients undergoing elective surgery under general anesthesia, the correct placement of supraglottic airway devices (iGel vs. Air-Q sp3G) will be assessed using fiberoptic bronchoscopy grading (Grade 3-4 considered correct positioning).
Gastric insufflation volume
时间窗: gastric volume will be measured intraoperatively
Gastric volume will be measured by ultrasound (USG) at three time points: Baseline (pre-induction): After IV induction, in supine position, before SGA insertion. Post-SGA insertion: Immediately after supraglottic airway (i-Gel or Air-Q sp3G) placement. End of surgery: Before emergence from anesthesia. The change in gastric volume across these time points will be compared between i-Gel and Air-Q sp3G groups.
次要结局
- Peak Airway Pressure(Intraoperative - immediately after insertion)
- Number of Attempts for Successful SGA Placement(Intraoperative)
- Postoperative Sore Throat(6 hours postoperative)
- Postoperative Hoarseness(6 hours postoperative)
- Postoperative Dysphagia(6 hours postoperative)
- Incidence of mucosal bleeding(6 hours postoperative)
- Incidence of nausea(6 hours postoperative)