Ultrasonographic Subglottic Airway Measurements and Postoperative Respiratory Events in Young Children

February 5, 2026 updated by: Gürcan Güler, Bursa Sevket Yilmaz Training and Research Hospital

Association Between Ultrasonographic Subglottic Airway Measurements and Postoperative Respiratory Adverse Events in Children Under Three Years of Age

This study aims to better understand postoperative respiratory adverse events that may occur in some children under three years of age undergoing airway management during surgery. As part of the study, ultrasonographic measurements of a portion of the upper airway will be performed during surgery using a non-invasive ultrasound device. These measurements will be evaluated in relation to perioperative respiratory outcomes. The results of this study may contribute to improved understanding of airway-related factors associated with postoperative respiratory safety in young children.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

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

Study Contact

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

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of children under three years of age scheduled for elective surgery under general anesthesia. All participants undergo planned airway management with a laryngeal mask airway and intraoperative ultrasonographic assessment of the subglottic airway as part of routine clinical care. Written informed consent is obtained from a parent or legal guardian prior to participation.

Description

Inclusion Criteria:

  • Children aged 0 to 35 months
  • Scheduled for elective surgery under general anesthesia
  • Planned airway management with a laryngeal mask airway
  • Ability to perform intraoperative ultrasonographic subglottic airway measurements
  • Written informed consent obtained from a parent or legal guardian

Exclusion Criteria:

  • Known congenital or acquired airway anomalies
  • Craniofacial anomalies
  • Emergency surgical procedures
  • Planned tracheal intubation instead of laryngeal mask airway
  • Inability to obtain adequate ultrasonographic subglottic airway measurements

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
Pediatric patients under three years of age
This cohort includes children under three years of age undergoing elective surgery. As part of routine perioperative care, ultrasonographic measurements of the subglottic airway are performed during surgery. Participants are followed postoperatively for the occurrence of respiratory-related adverse events.
Other: Ultrasonographic subglottic airway measurement
Non-invasive ultrasonographic measurement of the subglottic airway performed intraoperatively as part of routine clinical care. No therapeutic intervention is applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative respiratory adverse events (PRAE)
Time Frame: immediately after the surgery
The occurrence of clinically significant perioperative respiratory adverse events, defined as moderate to severe stridor and/or laryngospasm requiring clinical intervention, including positive pressur
immediately after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasonographic subglottic airway dimensions and area
Time Frame: During surgery
Subglottic airway mediolateral and anteroposterior diameters and the calculated subglottic cross-sectional area measured using ultrasonography at predefined intraoperative time points (T0, T1, and T2). Changes in subglottic airway area between time points (T0-T1, T1-T2, and T0-T2) will also be evaluated.
During surgery

Collaborators and Investigators

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

Sponsor

Bursa Sevket Yilmaz Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024-TBEK 2025/12-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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