Fiberoptic Evaluation of i-Gel and Air-Q sp3G Supraglottic Airway Devices in Pediatric Patients

NCT07141498 | Completed

• 1 other identifier: igelvsAirqFOB
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngeal Mask Airways; Fiberoptic Bronchoscopy (FOB); Elective Surgeries; Gastric Insufflation; Gastric Ultrasound

Keywords

laryngeal mask; airway management; ultrasonography; child

Outcome Measures

Primary Outcomes (2)

• Correct SGA Placement Rate via Fiberoptic Bronchoscopy

  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).

  Device placement will be assessed intraoperatively

• Gastric insufflation volume

  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.

  gastric volume will be measured intraoperatively

Secondary Outcomes (7)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 1-8 years (ASA I-III) undergoing elective pediatric surgery under general anesthesia at Ankara Bilkent City Hospital. Eligible participants will require supraglottic airway device placement (i-Gel or Air-Q sp3G).

You may qualify if:

• Age 1-8 years
• ASA I-III
• Elective pediatric or urological surgery under general anesthesia with SGA use
• Informed consent obtained from parents/guardians

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital, Department Of Anesthesiology and Reanimation

Ankara, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: August 28, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 9, 2026
• Last Updated: March 24, 2026

Record last verified: 2025-08

Locations

TU (1)