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

Ankara City Hospital

Status: Not yet enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT07141498

igelvsAirqFOB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 1 to 8 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

igel

Description:

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

Description:

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.