Comparison of Two Airway Devices (I-Gel and Air-Q) in Children Aged 1-10 Years During General Ane… (NCT07522957) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of Two Airway Devices (I-Gel and Air-Q) in Children Aged 1-10 Years During General Anesthesia
Turkey (Türkiye)60 participantsStarted 2026-04
Plain-language summary
This study aims to compare two commonly used airway devices (I-gel and Air-Q) in children aged 1-10 years undergoing general anesthesia for surgery. These devices help doctors keep the airway open and support breathing during the operation. The study will evaluate how well each device works, how easy they are to place, and whether they cause air to enter the stomach. Ultrasound will be used to safely check the position of the device and detect any air in the stomach. The results of this study may help improve the safety and effectiveness of airway management in children during anesthesia.
Who can participate
Age range
1 Year – 10 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:
* Children aged 1-10 years
* American Society of Anesthesiologists (ASA) physical status I-II
* Scheduled for elective (non-emergency) surgery under general anesthesia
* Planned use of a supraglottic airway device for airway management
* Written informed consent obtained from a parent or legal guardian
Exclusion Criteria:
* History of conditions associated with increased risk of aspiration (e.g., gastroesophageal reflux)
* Known or predicted difficult airway (e.g., Mallampati score ≥ 3)
* Congenital or acquired abnormalities of the face, neck, or upper airway
* Active upper respiratory tract infection
* Presence of significant pulmonary disease (e.g., asthma, bronchopulmonary dysplasia, cystic fibrosis)
* Body mass index above the 95th percentile for age (morbid obesity)
* Emergency surgery
* Previous complications related to supraglottic airway device use
* Failure of device placement or need to switch to an alternative airway management technique
* Refusal of participation by parent or legal guardian
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
Oropharyngeal Leak Pressure (OLP)
Timeframe: Immediately after device placement and at the end of the surgical procedure during anesthesia