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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I-Gel Group | Participants in this group will receive the I-gel laryngeal mask airway during general anesthesia. After placement, oropharyngeal leak pressure will be measured, and ultrasonography will be used to assess device position and detect gastric insufflation. Additional parameters such as insertion time, ease of insertion, and perioperative complications will be recorded. |
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| Air-Q SP Group | Participants in this group will receive the Air-Q SP laryngeal mask airway during general anesthesia. Similar measurements will be performed, including oropharyngeal leak pressure, ultrasonographic evaluation of device position and gastric insufflation, insertion time, ease of insertion, and perioperative complications. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I-gel supraglottic airway device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Immediately after device placement and at the end of the surgical procedure during anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric Insufflation | Assessed using ultrasonography by measuring gastric antral cross-sectional area (CSA) after device placement and at the end of surgery. | Immediately after device placement and at the end of surgery |
| Device Position |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Etlik City Hospital | Recruiting | Ankara | Etlik | 06170 | Turkey (Türkiye) |
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| Air-Q SP supraglottic airway device | 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. |
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Evaluated using ultrasonography to assess anatomical alignment at predefined time points.
| 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. | At the time of device placement (periprocedural) |
| Ease of Insertion | Assessed by the operator using a subjective scoring scale (1-4). | 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. | From device placement until discharge from the Post-Anesthesia Care Unit (PACU), up to 2 hours |