Fiberoptic Evaluation of i-Gel and Air-Q sp3G Supraglottic Airway Devices in Pediatric Patients (NCT07141498) | Clinical Trial Compass
CompletedNot Applicable
Fiberoptic Evaluation of i-Gel and Air-Q sp3G Supraglottic Airway Devices in Pediatric Patients
Turkey (Türkiye)91 participantsStarted 2025-08-28
Plain-language 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.
Who can participate
Age range
1 Year – 8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correct SGA Placement Rate via Fiberoptic Bronchoscopy
Timeframe: Device placement will be assessed intraoperatively
2
Gastric insufflation volume
Timeframe: gastric volume will be measured intraoperatively