Ultrasonographic Subglottic Airway Measurements and Postoperative Respiratory Events in Young Children

NCT07394686 | Not Yet Recruiting

• 1 other identifier: 2024-TBEK 2025/12-01
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Respiratory Complications; Perioperative Respiratory Adverse Events

Keywords

Postoperative Respiratory Complications; Pediatric airway; Pediatric airway evaluation; Subglottic airway measurements

Outcome Measures

Primary Outcomes (1)

• Perioperative respiratory adverse events (PRAE)

  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 Outcomes (1)

• Ultrasonographic subglottic airway dimensions and area

  During surgery

Study Arms (1)

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

Interventions

Ultrasonographic subglottic airway measurement OTHER

Non-invasive ultrasonographic measurement of the subglottic airway performed intraoperatively as part of routine clinical care. No therapeutic intervention is applied.

Pediatric patients under three years of age

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa Sevket Yilmaz Training and Research Hospital: lead

Study Sites (1)

Principal Investigator

Bursa, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 40994506 RESULT

• Altun 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.

  PMID: 28058141 RESULT

Central Study Contacts

Gürcan Güler

CONTACT

+90 541 975 0407; gurcanguler.45@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 6, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)