Actively Recruiting
Effect of I-gel and Air-Q SP LMAs on Oropharyngeal Leak Pressure and Gastric Insufflation in Children: An Ultrasonography-Guided Randomized Study
Led by Ankara Etlik City Hospital · Updated on 2026-04-23
60
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating two airway devices, I-gel and Air-Q, in children aged 1 to 10 years undergoing general anesthesia for surgery. These devices help keep the airway open to support breathing during the operation. The study aims to compare how well each device works, how easy they are to place, and whether they cause air to enter the stomach, which can be an unwanted side effect. Ultrasound imaging will be used to safely check the device's position and detect any air in the stomach. Children in this study will be randomly assigned to receive either the I-gel or Air-Q supraglottic airway device during general anesthesia. The devices are selected based on the child's weight and placed according to standard clinical practice. Researchers will measure oropharyngeal leak pressure, insertion time, ease of insertion, and monitor for any complications. Ultrasound will be performed immediately after device placement, after patient positioning, and at the end of surgery to assess device position and gastric insufflation. Participants will undergo standard care with no additional risks beyond routine anesthesia. Data collected include measurements of airway sealing, device positioning, insertion details, and any complications from placement until discharge from the post-anesthesia care unit. The primary outcome is oropharyngeal leak pressure measured immediately after placement and at surgery end. The study may help improve airway device choice and safety for children during anesthesia. Total participation duration matches the surgical procedure and immediate recovery period.
CONDITIONS
Brief Title
Comparison of Two Airway Devices (I-Gel and Air-Q) in Children Aged 1-10 Years During General Anesthesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- History of conditions associated with increased risk of aspiration (e.g., gastroesophageal reflux)
- Known or predicted difficult airway (e.g., Mallampati score 63 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of surgical procedure under general anesthesia
Participants receive either the I-gel or Air-Q SP supraglottic airway device during general anesthesia as part of their scheduled surgery. Ultrasonography is used to assess device position and detect gastric insufflation immediately after device placement and at the end of surgery.
1 visit (during surgery)
Duration - Up to 2 hours post-surgery
Participants are monitored for perioperative complications from device placement until discharge from the Post-Anesthesia Care Unit, up to 2 hours after surgery.
Approximately 1 post-operative visit (in-person)
Trial Site Locations
Total: 1 location
1
Ankara Etlik City Hospital
Ankara, Etlik, Turkey (Türkiye), 06170
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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