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

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

Recruiting
1-10 years
All
Phase N/A

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Overview

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.

Description

This study is designed to compare two commonly used airway devices, I-gel and Air-Q, in children aged 1-10 years who are undergoing surgery under general anesthesia. These devices are used by anesthesiologists to keep the airway open and allow safe breathing during the procedure. Although both devices are widely used in clinical practice, their performance and safety in children may differ.

In this study, children will be randomly assigned to receive one of the two devices during anesthesia. The researchers will measure how effectively each device seals the airway, how easy and quick it is to place, and whether it causes air to enter the stomach, which can be an unwanted effect. Ultrasound imaging, a safe and non-invasive method, will be used to assess both the position of the device and the presence of air in the stomach.

All procedures performed in this study are part of standard clinical care, and no additional risks beyond routine anesthesia practice are expected. The information obtained from this study may help doctors choose the most effective and safest airway device for children, thereby improving the quality of anesthesia care and reducing potential complications.

Eligibility

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

Study details
    Anesthesia General
    Ultrasonography
    Laryngeal Mask Airways
    Airway Management
    Child

NCT07522957

Ankara Etlik City Hospital

13 May 2026

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