Perioperative Respiratory Adverse EventsNCT07394686
Ultrasonographic Subglottic Airway Measurements and Postoperative Respiratory Events in Young Children
An observational study of Perioperative Respiratory Adverse Events and Postoperative Respiratory Complications, run by Bursa Sevket Yilmaz Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to better understand airway-related respiratory events that may occur in children under three years of age undergoing general anesthesia with a laryngeal mask airway (LMA). Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Perioperative Respiratory Adverse Events, Postoperative Respiratory Complications
- What is being tested?
- Serial subglottic airway ultrasonography
- How many people
- 139 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 30 Jun 2026
- 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 Up to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population consists of children aged 0 to 35 months scheduled for elective surgery under general anesthesia with planned airway management using a laryngeal mask airway. Participants undergo serial intraoperative ultrasonographic assessment of the subglottic airway for observational study purposes. The ultrasonographic assessments do not alter routine anesthetic or airway management. Written informed consent is obtained from a parent or legal guardian prior to participation.
Who may be able to join
- Children aged 0 to 35 months
- Scheduled for elective surgery under general anesthesia
- Planned airway management with a laryngeal mask airway
- Written informed consent obtained from a parent or legal guardian
Who cannot join
- Known congenital or acquired airway anomalies
- Craniofacial anomalies
- Emergency surgical procedures
- Planned tracheal intubation instead of laryngeal mask airway
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa
About this study
Official title: Association Between Ultrasonographic Subglottic Airway Measurements and Postoperative Respiratory Adverse Events in Children Under Three Years of Age
This study aims to better understand airway-related respiratory events that may occur in children under three years of age undergoing general anesthesia with a laryngeal mask airway (LMA). As part of the study, ultrasonographic measurements of the subglottic airway will be performed at different time points during anesthesia using a non-invasive ultrasound device. Changes in these measurements will be evaluated in relation to intervention-requiring upper-airway events occurring during anesthesia, LMA removal, or early recovery. The results may contribute to a better understanding of airway-related factors associated with respiratory events in young children undergoing anesthesia with an LMA.
Read the detailed description
Young children are particularly susceptible to airway-related respiratory events during general anesthesia and emergence. Changes in upper-airway dimensions occurring during anesthesia and airway device use may contribute to these events, but their relationship with clinically relevant airway events remains incompletely understood.
This prospective observational study evaluates serial ultrasonographic measurements of the subglottic airway in children under three years of age undergoing general anesthesia with a laryngeal mask airway. Measurements obtained at different stages of anesthesia are examined in relation to intervention-requiring upper-airway events occurring during anesthesia, laryngeal mask airway removal, or early recovery. The study also evaluates clinical, airway-management, and ventilatory characteristics that may be associated with these events.
- Being tested
- Serial subglottic airway ultrasonography
- Keywords
- Postoperative Respiratory Complications, Pediatric airway, Pediatric airway evaluation, Subglottic airway measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial subglottic airway ultrasonographyDiagnostic test
Non-invasive ultrasonographic assessment of the subglottic airway performed at predefined time points during general anesthesia. Medioloateral and anteroposterior airway dimensions were measured to evaluate serial changes in subglottic airway geometry. The ultrasonographic assessments were performed for observational study purposes and did not alter routine anesthetic or airway management.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients under three years of age | This cohort includes children under three years of age undergoing elective surgery under general anesthesia with a laryngeal mask airway (LMA). Serial ultrasonographic measurements of the subglottic airway are obtained at predefined time points during anesthesia. Participants are observed for intervention-requiring upper-airway events occurring during anesthesia, LMA removal, or early postoperative recovery. Receives: Diagnostic Test: Serial subglottic airway ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention-requiring upper-airway events
Occurrence of clinically apparent moderate-to-severe stridor and/or laryngospasm requiring airway intervention, including positive-pressure ventilation or CPAP, deepening of anesthesia, neuromuscular blockade, i-gel repositioning or replacement, endotracheal intubation, or pharmacological treatment. Repositioning or replacement due to suspected device malposition alone was not considered an event. Oxygen desaturation alone was not included in the primary outcome.
Measured: During anesthesia, at i-gel removal, and during early postanesthesia care unit observation (same surgical encounter).
Secondary outcomes (1)
Serial changes in ultrasonographic subglottic airway dimensions
Mediolateral and anteroposterior subglottic diameters were measured using ultrasonography at three perioperative time points. Ellipse-derived area was calculated from these measurements. Changes in diameters and calculated area between T0, T1, and T2 were assessed, with T0-T2 representing the principal interval of interest.
Measured: T0: after induction, before i-gel insertion; T1: after insertion during stable ventilation; T2: immediately before emergence with the i-gel in situ.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Mar 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Why it stopped: Recruitment was stopped earlier than initially planned following an investigator decision that the available sample was sufficient for exploratory analysis. A total of 139 participants were enrolled, compared with the initially estimated 350.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perioperative Respiratory Adverse EventsStudies of the same condition, open and under way.
- 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
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Sevket Yilmaz Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gürcan Güler, Bursa Sevket Yilmaz Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394686
- Sponsor's protocol ID
- 2024-TBEK 2025/12-01
- Status last verified
- Oct 2026
- First submitted
- 29 Jan 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sayan O, Erbas M, Sayan M. Association of postoperative airway complications with ultrasonographic measurements in pediatric patients: An exploratory analysis. Saudi J Anaesth. 2025 Oct-Dec;19(4):535-545. doi: 10.4103/sja.sja_215_25. Epub 2025 Sep 3.
PubMed 40994506Altun D, Sungur MO, Ali A, Bingul ES, Seyhan TO, Camci E. Ultrasonographic Measurement of Subglottic Diameter for Paediatric Cuffed Endotracheal Tube Size Selection: Feasibility Report. Turk J Anaesthesiol Reanim. 2016 Dec;44(6):301-305. doi: 10.5152/TJAR.2016.60420. Epub 2016 Dec 1.
PubMed 28058141
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Ultrasonographic Subglottic Airway Measurements and Postoperative Respiratory Adverse Events in Children Under Three Years of Age
- ClinicalTrials.gov ID
- NCT07394686
- Acronym / sponsor ID
- 2024-TBEK 2025/12-01
- Keywords
- Postoperative Respiratory Complications, Pediatric airway, Pediatric airway evaluation, Subglottic airway measurements
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment was stopped earlier than initially planned following an investigator decision that the available sample was sufficient for exploratory analysis. A total of 139 participants were enrolled, compared with the initially estimated 350.
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Bursa Sevket Yilmaz Training and Research HospitalOther government
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 6 Feb 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 better understand airway-related respiratory events that may occur in children under three years of age undergoing general anesthesia with a laryngeal mask airway (LMA). As part of the study, ultrasonographic measurements of the subglottic airway will be performed at different time points during anesthesia using a non-invasive ultrasound device. Changes in these measurements will be evaluated in relation to intervention-requiring upper-airway events occurring during anesthesia, LMA removal, or early recovery. The results may contribute to a better understanding of airway-related factors associated with respiratory events in young children undergoing anesthesia with an LMA.
Detailed description
Young children are particularly susceptible to airway-related respiratory events during general anesthesia and emergence. Changes in upper-airway dimensions occurring during anesthesia and airway device use may contribute to these events, but their relationship with clinically relevant airway events remains incompletely understood.
This prospective observational study evaluates serial ultrasonographic measurements of the subglottic airway in children under three years of age undergoing general anesthesia with a laryngeal mask airway. Measurements obtained at different stages of anesthesia are examined in relation to intervention-requiring upper-airway events occurring during anesthesia, laryngeal mask airway removal, or early recovery. The study also evaluates clinical, airway-management, and ventilatory characteristics that may be associated with these events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients under three years of age | – | Diagnostic Test: Serial subglottic airway ultrasonographyThis cohort includes children under three years of age undergoing elective surgery under general anesthesia with a laryngeal mask airway (LMA). Serial ultrasonographic measurements of the subglottic airway are obtained at predefined time points during anesthesia. Participants are observed for intervention-requiring upper-airway events occurring during anesthesia, LMA removal, or early postoperative recovery. |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consists of children aged 0 to 35 months scheduled for elective surgery under general anesthesia with planned airway management using a laryngeal mask airway. Participants undergo serial intraoperative ultrasonographic assessment of the subglottic airway for observational study purposes. The ultrasonographic assessments do not alter routine anesthetic or airway management. Written informed consent is obtained from a parent or legal guardian prior to participation.
Key inclusion criteria (4 listed)
- Children aged 0 to 35 months
- Scheduled for elective surgery under general anesthesia
- Planned airway management with a laryngeal mask airway
- Written informed consent obtained from a parent or legal guardian
Key exclusion criteria (4 listed)
- Known congenital or acquired airway anomalies
- Craniofacial anomalies
- Emergency surgical procedures
- Planned tracheal intubation instead of laryngeal mask airway
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 |
|---|---|---|
| Serial subglottic airway ultrasonographyNon-invasive ultrasonographic assessment of the subglottic airway performed at predefined time points during general anesthesia. Medioloateral and anteroposterior airway dimensions were measured to evaluate serial changes in subglottic airway geometry. The ultrasonographic assessments were performed for observational study purposes and did not alter routine anesthetic or airway management. | Diagnostic test | Pediatric patients under three years of age |
Primary outcome
Intervention-requiring upper-airway events
Time frame: During anesthesia, at i-gel removal, and during early postanesthesia care unit observation (same surgical encounter).
Occurrence of clinically apparent moderate-to-severe stridor and/or laryngospasm requiring airway intervention, including positive-pressure ventilation or CPAP, deepening of anesthesia, neuromuscular blockade, i-gel repositioning or replacement, endotracheal intubation, or pharmacological treatment. Repositioning or replacement due to suspected device malposition alone was not considered an event. Oxygen desaturation alone was not included in the primary outcome.
1 secondary outcome
Serial changes in ultrasonographic subglottic airway dimensions
Time frame: T0: after induction, before i-gel insertion; T1: after insertion during stable ventilation; T2: immediately before emergence with the i-gel in situ.
Results and safety
The study was stopped early (reason given: Recruitment was stopped earlier than initially planned following an investigator decision that the available sample was sufficient for exploratory analysis. A total of 139 participants were enrolled, compared with the initially estimated 350.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: PubMed 40994506Sayan O, Erbas M, Sayan M. Association of postoperative airway complications with ultrasonographic measurements in pediatric patients: An exploratory analysis. Saudi J Anaesth. 2025 Oct-Dec;19(4):535-545. doi: 10.4103/sja.sja_215_25. Epub 2025 Sep 3.
- Background: PubMed 28058141Altun D, Sungur MO, Ali A, Bingul ES, Seyhan TO, Camci E. Ultrasonographic Measurement of Subglottic Diameter for Paediatric Cuffed Endotracheal Tube Size Selection: Feasibility Report. Turk J Anaesthesiol Reanim. 2016 Dec;44(6):301-305. doi: 10.5152/TJAR.2016.60420. Epub 2016 Dec 1.
- Individual participant dataSharing planned: No
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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 Perioperative Respiratory Adverse Events and Postoperative Respiratory Complications, run by Bursa Sevket Yilmaz Training and Research 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 15 Oct 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 was stopped early (reason given: Recruitment was stopped earlier than initially planned following an investigator decision that the available sample was sufficient for exploratory analysis. A total of 139 participants were enrolled, compared with the initially estimated 350.). Results are not available in the source record.
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?
Intervention-requiring upper-airway events (time frame: During anesthesia, at i-gel removal, and during early postanesthesia care unit observation (same surgical encounter).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07394686, which also lists 2 linked publications.
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 15 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.