Laryngeal Mask AirwaysNCT07141498
Fiberoptic Evaluation of i-Gel and Air-Q sp3G Supraglottic Airway Devices in Pediatric Patients
An observational study of Laryngeal Mask Airways and Fiberoptic Bronchoscopy (FOB), run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This single-center, prospective, randomized controlled study aims to compare the placement accuracy of iGel and Air-Q sp3G supraglottic airway (SGA) devices in pediatric patients aged 1-8 years undergoing elective surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 1 year to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Laryngeal Mask Airways, Fiberoptic Bronchoscopy (FOB), Elective Surgeries
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Aug 2025to 9 Jan 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 1-8 years (ASA I-III) undergoing elective pediatric surgery under general anesthesia at Ankara Bilkent City Hospital. Eligible participants will require supraglottic airway device placement (i-Gel or Air-Q sp3G).
Who may be able to join
- Age 1-8 years
- ASA I-III
- Elective pediatric or urological surgery under general anesthesia with SGA use
- Informed consent obtained from parents/guardians
Who cannot join
- Parental refusal or inability to consent
- ASA > III
- Recent or current upper respiratory tract infection
- History of difficult airway
- Increased aspiration risk
- Urgent/emergency surgery or non-fasted patients
Show all 11Show fewer
- Known allergy or contraindication to anesthetic agents
- Severe asthma (attack within last 6 months)
- Structural airway anomalies
- Gastrointestinal pathology affecting stomach emptying
- Previous stomach surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital, Department Of Anesthesiology and Reanimation
Ankara
About this study
Official title: Evaluation of i-Gel and Air-Q sp3G Supraglottic Airway Device Placement by Fiberoptic Bronchoscopy and Comparison of Gastric Insufflation Volumes Using Ultrasound in Pediatric Patient
This single-center, prospective, randomized controlled study aims to compare the placement accuracy of iGel and Air-Q sp3G supraglottic airway (SGA) devices in pediatric patients aged 1-8 years undergoing elective surgery under general anesthesia. Placement will be confirmed via fiberoptic bronchoscopy, and gastric insufflation will be assessed using ultrasound measurement of gastric antral cross-sectional area pre- and post-device placement. Secondary outcomes include postoperative complications such as sore throat, hoarseness and dysphagia.
Read the detailed description
This single-center, prospective, randomized controlled trial will be conducted in pediatric patients aged 1-8 years undergoing elective pediatric or urological surgery under general anesthesia. Participants will be randomized into two groups to receive either an iGel or an Air-Q sp3G device. Device placement will be confirmed intraoperatively via fiberoptic bronchoscopy using a standardized grading system and gastric antral cross-sectional area will be measured with ultrasound before device insertion, immediately after insertion and at the end of surgery to evaluate gastric insufflation.
Secondary outcomes will include postoperative complications such as sore throat, hoarseness, dysphagia, mucosal bleeding, cough, laryngospasm, bronchospasm, nausea, vomiting and stridor. Intraoperative variables such as number of insertion attempts, ease of placement and peak airway pressure will also be recorded. The results are expected to identify which device offers better placement accuracy and lower gastric insufflation rates, thereby improving perioperative safety and postoperative recovery in pediatric patients.
- Conditions
- Laryngeal Mask Airways, Fiberoptic Bronchoscopy (FOB), Elective Surgeries, Gastric Insufflation, Gastric Ultrasound
- Keywords
- laryngeal mask, airway management, ultrasonography, child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| igel | Pediatric patients aged 1-8 years undergoing elective pediatric or urological surgery under general anesthesia. Supraglottic airway (SGA) management will be performed using the igel second-generation device. Position verification will be performed via fiberoptic bronchoscopy (Grade 3-4 accepted as correct). Gastric volume will be measured with USG pre-insertion, post-insertion, and at surgery completion. Pre-, intra-, and postoperative complications will be documented as in the iGel group. | |
| Air-Q sp3G | Pediatric patients aged 1-8 years undergoing elective pediatric or urological surgery under general anesthesia. Supraglottic airway (SGA) management will be performed using the Air-Q sp3G second-generation device. Position verification will be performed via fiberoptic bronchoscopy (Grade 3-4 accepted as correct). Gastric volume will be measured with USG pre-insertion, post-insertion, and at surgery completion. Pre-, intra-, and postoperative complications will be documented as in the iGel group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct SGA Placement Rate via Fiberoptic Bronchoscopy
In pediatric patients undergoing elective surgery under general anesthesia, the correct placement of supraglottic airway devices (iGel vs. Air-Q sp3G) will be assessed using fiberoptic bronchoscopy grading (Grade 3-4 considered correct positioning).
Measured: Device placement will be assessed intraoperatively
Gastric insufflation volume
Gastric volume will be measured by ultrasound (USG) at three time points:
Baseline (pre-induction): After IV induction, in supine position, before SGA insertion.
Post-SGA insertion: Immediately after supraglottic airway (i-Gel or Air-Q sp3G) placement.
End of surgery: Before emergence from anesthesia. The change in gastric volume across these time points will be compared between i-Gel and Air-Q sp3G groups.
Measured: gastric volume will be measured intraoperatively
Secondary outcomes (7)
Peak Airway Pressure
Peak inspiratory airway pressure measured intraoperatively after SGA placement
Measured: Intraoperative - immediately after insertion
Number of Attempts for Successful SGA Placement
Count of insertion attempts required to achieve correct SGA positioning
Measured: Intraoperative
Postoperative Sore Throat
Incidence of sore throat assessed by direct questioning at 6 hours after surgery.
Measured: 6 hours postoperative
Postoperative Hoarseness
Incidence of hoarseness assessed by direct questioning at 6 hours after surgery.
Measured: 6 hours postoperative
Postoperative Dysphagia
Incidence of swallowing difficulty assessed at 6 hours after surgery
Measured: 6 hours postoperative
Incidence of mucosal bleeding
Incidence of mucosal bleeding assessed by direct questioning at 6 hours after surgery.
Measured: 6 hours postoperative
Incidence of nausea
Incidence of nausea assessed by direct questioning at 6 hours after surgery
Measured: 6 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start28 Aug 2025
- Primary completion30 Dec 2025
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal Mask AirwaysStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141498
- Sponsor's protocol ID
- igelvsAirqFOB
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of i-Gel and Air-Q sp3G Supraglottic Airway Device Placement by Fiberoptic Bronchoscopy and Comparison of Gastric Insufflation Volumes Using Ultrasound in Pediatric Patient
- ClinicalTrials.gov ID
- NCT07141498
- Acronym / sponsor ID
- igelvsAirqFOB
- Conditions
- Laryngeal Mask Airways, Fiberoptic Bronchoscopy (FOB), Elective Surgeries, Gastric Insufflation, Gastric Ultrasound
- Keywords
- laryngeal mask, airway management, ultrasonography, child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 26 Aug 2025 (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 single-center, prospective, randomized controlled study aims to compare the placement accuracy of iGel and Air-Q sp3G supraglottic airway (SGA) devices in pediatric patients aged 1-8 years undergoing elective surgery under general anesthesia. Placement will be confirmed via fiberoptic bronchoscopy, and gastric insufflation will be assessed using ultrasound measurement of gastric antral cross-sectional area pre- and post-device placement. Secondary outcomes include postoperative complications such as sore throat, hoarseness and dysphagia.
Detailed description
This single-center, prospective, randomized controlled trial will be conducted in pediatric patients aged 1-8 years undergoing elective pediatric or urological surgery under general anesthesia. Participants will be randomized into two groups to receive either an iGel or an Air-Q sp3G device. Device placement will be confirmed intraoperatively via fiberoptic bronchoscopy using a standardized grading system and gastric antral cross-sectional area will be measured with ultrasound before device insertion, immediately after insertion and at the end of surgery to evaluate gastric insufflation.
Secondary outcomes will include postoperative complications such as sore throat, hoarseness, dysphagia, mucosal bleeding, cough, laryngospasm, bronchospasm, nausea, vomiting and stridor. Intraoperative variables such as number of insertion attempts, ease of placement and peak airway pressure will also be recorded. The results are expected to identify which device offers better placement accuracy and lower gastric insufflation rates, thereby improving perioperative safety and postoperative recovery in pediatric patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| igel | – | –Pediatric patients aged 1-8 years undergoing elective pediatric or urological surgery under general anesthesia. Supraglottic airway (SGA) management will be performed using the igel second-generation device. Position verification will be performed via fiberoptic bronchoscopy (Grade 3-4 accepted as correct). Gastric volume will be measured with USG pre-insertion, post-insertion, and at surgery completion. Pre-, intra-, and postoperative complications will be documented as in the iGel group. |
| Air-Q sp3G | – | –Pediatric patients aged 1-8 years undergoing elective pediatric or urological surgery under general anesthesia. Supraglottic airway (SGA) management will be performed using the Air-Q sp3G second-generation device. Position verification will be performed via fiberoptic bronchoscopy (Grade 3-4 accepted as correct). Gastric volume will be measured with USG pre-insertion, post-insertion, and at surgery completion. Pre-, intra-, and postoperative complications will be documented as in the iGel group. |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 1-8 years (ASA I-III) undergoing elective pediatric surgery under general anesthesia at Ankara Bilkent City Hospital. Eligible participants will require supraglottic airway device placement (i-Gel or Air-Q sp3G).
Key inclusion criteria (4 listed)
- Age 1-8 years
- ASA I-III
- Elective pediatric or urological surgery under general anesthesia with SGA use
- Informed consent obtained from parents/guardians
Key exclusion criteria (11 listed)
- Parental refusal or inability to consent
- ASA > III
- Recent or current upper respiratory tract infection
- History of difficult airway
- Increased aspiration risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correct SGA Placement Rate via Fiberoptic Bronchoscopy
Time frame: Device placement will be assessed intraoperatively
In pediatric patients undergoing elective surgery under general anesthesia, the correct placement of supraglottic airway devices (iGel vs. Air-Q sp3G) will be assessed using fiberoptic bronchoscopy grading (Grade 3-4 considered correct positioning).
Gastric insufflation volume
Time frame: gastric volume will be measured intraoperatively
Gastric volume will be measured by ultrasound (USG) at three time points: Baseline (pre-induction): After IV induction, in supine position, before SGA insertion. Post-SGA insertion: Immediately after supraglottic airway (i-Gel or Air-Q sp3G) placement. End of surgery: Before emergence from anesthesia. The change in gastric volume across these time points will be compared between i-Gel and Air-Q sp3G groups.
7 secondary outcomes
Peak Airway Pressure
Time frame: Intraoperative - immediately after insertion
Number of Attempts for Successful SGA Placement
Time frame: Intraoperative
Postoperative Sore Throat
Time frame: 6 hours postoperative
Postoperative Hoarseness
Time frame: 6 hours postoperative
Postoperative Dysphagia
Time frame: 6 hours postoperative
Incidence of mucosal bleeding
Time frame: 6 hours postoperative
Incidence of nausea
Time frame: 6 hours postoperative
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 24 Mar 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 Laryngeal Mask Airways and Fiberoptic Bronchoscopy (FOB), run by Ankara City Hospital Bilkent 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 4 inclusion and 11 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 24 Mar 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?
Correct SGA Placement Rate via Fiberoptic Bronchoscopy (time frame: Device placement will be assessed intraoperatively). The study lists 2 primary outcomes in all. 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 24 Mar 2026.