RecruitingNCT07522957

Comparison of Two Airway Devices (I-Gel and Air-Q) in Children Aged 1-10 Years During General Anesthesia

Effect of I-gel and Air-Q SP LMAs on Oropharyngeal Leak Pressure and Gastric Insufflation in Children: An Ultrasonography-Guided Randomized Study

Sponsor

Ankara Etlik City Hospital

Enrollment

60 participants

Start Date

Apr 1, 2026

Study Type

OBSERVATIONAL

Conditions

Ultrasonography Airway Management Child Anesthesia General Laryngeal Mask Airways

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.

Eligibility

Min Age: 1 YearMax Age: 10 Years

Inclusion Criteria5

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 Criteria10

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

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Interventions

DEVICEI-gel supraglottic airway device

I-gel Laryngeal Mask Airway: The I-gel is a second-generation supraglottic airway device with a non-inflatable cuff designed to provide an anatomical seal of the airway. In this study, the device will be selected according to patient weight and inserted following standard clinical practice during general anesthesia. Its performance will be evaluated using oropharyngeal leak pressure measurements and ultrasonographic assessment of gastric insufflation and device position.

DEVICEAir-Q SP supraglottic airway device

Air-Q SP Laryngeal Mask Airway: The Air-Q SP is a supraglottic airway device with a self-pressurizing, non-inflatable cuff designed to provide effective airway sealing. It will be selected based on patient weight and inserted using standard techniques. Its performance will be assessed using the same parameters as the I-gel, including oropharyngeal leak pressure, ultrasonographic evaluation of gastric insufflation, and device positioning.