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

April 21, 2026 updated by: Ulku Yavuz Ersayin, Ankara Etlik City Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: 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.

Other Names:
  • I-gel laryngeal mask airway
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.
Device: 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.

Other Names:
  • Air-Q SP laryngeal mask airway

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Immediately after device placement and at the end of the surgical procedure during anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric Insufflation
Time Frame: Immediately after device placement and at the end of surgery
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
Time Frame: Immediately after device placement, after patient positioning, and at the end of surgery
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
Time Frame: At the time of device placement (periprocedural)
Measured in seconds from picking up the device to achieving effective ventilation.
At the time of device placement (periprocedural)
Ease of Insertion
Time Frame: At the time of device placement (periprocedural)
Assessed by the operator using a subjective scoring scale (1-4).
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Etlik City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

April 5, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AEŞH-EK-2025-261

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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