Anesthesia GeneralNCT07522957
Comparison of Two Airway Devices (I-Gel and Air-Q) in Children Aged 1-10 Years During General Anesthesia
An observational study of Anesthesia General and Ultrasonography, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia General, Ultrasonography, Laryngeal Mask Airways
- What is being tested?
- I-gel supraglottic airway device and Air-Q SP supraglottic airway device
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 1 Oct 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study 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.
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Etlik, 06170
About this study
Official title: Effect of I-gel and Air-Q SP LMAs on Oropharyngeal Leak Pressure and Gastric Insufflation in Children: An Ultrasonography-Guided Randomized Study
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.
Read the detailed 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.
- Being tested
- I-gel supraglottic airway device, Air-Q SP supraglottic airway device
- Keywords
- Airway management, Laryngeal mask airway, Pediatric patients, Ultrasonography, Gastric insufflation, Supraglottic airway devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-gel supraglottic airway deviceDevice
Also called I-gel laryngeal mask airway
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
Also called Air-Q SP laryngeal mask airway
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: I-gel supraglottic airway device | |
| 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. Receives: Device: Air-Q SP supraglottic airway device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Immediately after device placement and at the end of the surgical procedure during anesthesia
Secondary outcomes (5)
Gastric Insufflation
Assessed using ultrasonography by measuring gastric antral cross-sectional area (CSA) after device placement and at the end of surgery.
Measured: Immediately after device placement and at the end of surgery
Device Position
Evaluated using ultrasonography to assess anatomical alignment at predefined time points.
Measured: 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.
Measured: At the time of device placement (periprocedural)
Ease of Insertion
Assessed by the operator using a subjective scoring scale (1-4).
Measured: 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.
Measured: From device placement until discharge from the Post-Anesthesia Care Unit (PACU), up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Apr 2026
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia GeneralStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ulku Yavuz Ersayin, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522957
- Sponsor's protocol ID
- AEŞH-EK-2025-261
- Status last verified
- Oct 2026
- First submitted
- 27 Mar 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of I-gel and Air-Q SP LMAs on Oropharyngeal Leak Pressure and Gastric Insufflation in Children: An Ultrasonography-Guided Randomized Study
- ClinicalTrials.gov ID
- NCT07522957
- Acronym / sponsor ID
- AEŞH-EK-2025-261
- Keywords
- Airway management, Laryngeal mask airway, Pediatric patients, Ultrasonography, Gastric insufflation, Supraglottic airway devices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-Gel Group | – | Device: I-gel supraglottic airway deviceParticipants 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. |
| Air-Q SP Group | – | Device: Air-Q SP supraglottic airway deviceParticipants 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. |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-gel supraglottic airway deviceAlso: I-gel laryngeal mask airwayI-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. | Device | I-Gel Group |
| Air-Q SP supraglottic airway deviceAlso: Air-Q SP laryngeal mask airwayAir-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. | Device | Air-Q SP Group |
Primary outcome
Oropharyngeal Leak Pressure (OLP)
Time frame: Immediately after device placement and at the end of the surgical procedure during anesthesia
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).
5 secondary outcomes
Gastric Insufflation
Time frame: Immediately after device placement and at the end of surgery
Device Position
Time frame: Immediately after device placement, after patient positioning, and at the end of surgery
Insertion Time
Time frame: At the time of device placement (periprocedural)
Ease of Insertion
Time frame: At the time of device placement (periprocedural)
Perioperative Complications
Time frame: From device placement until discharge from the Post-Anesthesia Care Unit (PACU), up to 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia General and Ultrasonography, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oropharyngeal Leak Pressure (OLP) (time frame: Immediately after device placement and at the end of the surgical procedure during anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.