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

NCT07522957 | Recruiting FDA Device

• 1 other identifier: AEŞH-EK-2025-261
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anesthesia General; Ultrasonography; Laryngeal Mask Airways; Airway Management; Child

Keywords

Airway management; Laryngeal mask airway; Pediatric patients; Ultrasonography; Gastric insufflation; Supraglottic airway devices

Outcome Measures

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).

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

Secondary Outcomes (5)

• Gastric Insufflation

  Immediately after device placement and at the end of surgery

• Device Position

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

• Insertion Time

  At the time of device placement (periprocedural)

• Ease of Insertion

  At the time of device placement (periprocedural)

• Perioperative Complications

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

Study Arms (2)

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

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

Interventions

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.

Also known as: I-gel laryngeal mask airway

I-Gel Group

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.

Also known as: Air-Q SP laryngeal mask airway

Air-Q SP Group

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Etlik, 06170, Turkey (Türkiye)

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

TU (1)