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

N/ANot Yet RecruitingNCT07522957

Ankara Etlik City Hospital60 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Anesthesia General Ultrasonography

Interventions

I-gel supraglottic airway deviceDEVICE

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.

Air-Q SP supraglottic airway deviceDEVICE

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.

Eligibility

Sex: ALLMin age: 1 YearMax age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Oropharyngeal Leak Pressure (OLP)

Measured in cmH₂O after device placement and at the end of surgery using standard anesthesia machine settings (fresh gas flow 3 L/min, APL valve set to 30 cmH₂O).

Time frame: Immediately after device placement and at the end of the surgical procedure during anesthesia

Secondary Outcomes

Gastric Insufflation

Assessed using ultrasonography by measuring gastric antral cross-sectional area (CSA) after device placement and at the end of surgery.

Time frame: Immediately after device placement and at the end of surgery

Device Position

Evaluated using ultrasonography to assess anatomical alignment at predefined time points.

Time frame: Immediately after device placement, after patient positioning, and at the end of surgery

Insertion Time

Measured in seconds from picking up the device to achieving effective ventilation.

Time frame: At the time of device placement (periprocedural)

Ease of Insertion

Assessed by the operator using a subjective scoring scale (1-4).

Time frame: At the time of device placement (periprocedural)

Perioperative Complications

Recorded as the occurrence of events such as desaturation, laryngospasm, coughing, vomiting, or blood staining on the device.

Time frame: From device placement until discharge from the Post-Anesthesia Care Unit (PACU), up to 2 hours