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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ankara City Hospital Bilkent
- Enrollment
- 91
- Locations
- 1
- Primary Endpoint
- Correct SGA Placement Rate via Fiberoptic Bronchoscopy
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Year to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 1-8 years
- •ASA I-III
- •Elective pediatric or urological surgery under general anesthesia with SGA use
- •Informed consent obtained from parents/guardians
Exclusion Criteria
- •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
Arms & Interventions
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.
Outcomes
Primary Outcomes
Correct SGA Placement Rate via Fiberoptic Bronchoscopy
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)