Comparison of Two Airway Devices (I-Gel and Air-Q) in Children Aged 1-10 Years During General Anesthesia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-10
SponsorAnkara Etlik City Hospital
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population will consist of children aged 1-10 years who are scheduled for elective surgical procedures under general anesthesia at a tertiary care hospital. Participants will be selected from patients with American Society of Anesthesiologists (ASA) physical status I-II, representing generally healthy pediatric individuals. All eligible patients will be recruited from the operating room setting after obtaining written informed consent from their parents or legal guardians.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
I-gel supraglottic airway device
DeviceI-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 device
DeviceAir-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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: I-Gel Group1 intervention
Group B: Air-Q SP Group1 intervention
Trial outcomes
Primary outcomes
1
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 anesthesiaSecondary outcomes
1
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 surgery2
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 surgery3
Insertion Time
Measured in seconds from picking up the device to achieving effective ventilation.
Time frame
At the time of device placement (periprocedural)4
Ease of Insertion
Assessed by the operator using a subjective scoring scale (1-4).
Time frame
At the time of device placement (periprocedural)Sponsors and contacts
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Source ClinicalTrials.gov