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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство I-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.
• Устройство Air-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.

Первичные конечные точки

• Oropharyngeal Leak Pressure (OLP) [Срок оценки: Immediately after device placement and at the end of the surgical procedure during anesthesia]

Вторичные конечные точки (5)

• Gastric Insufflation [Срок оценки: Immediately after device placement and at the end of surgery]
• Device Position [Срок оценки: Immediately after device placement, after patient positioning, and at the end of surgery]
• Insertion Time [Срок оценки: At the time of device placement (periprocedural)]
• Ease of Insertion [Срок оценки: At the time of device placement (periprocedural)]
• Perioperative Complications [Срок оценки: From device placement until discharge from the Post-Anesthesia Care Unit (PACU), up to 2 hours]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Ankara Etlik City Hospital — Ankara

Идентификаторы

NCT: NCT07522957 · AEŞH-EK-2025-261

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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