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Ultrasonographic Subglottic Airway Measurements and Postoperative Respiratory Events in Young Children

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07394686
Enrollment
350
Registered
2026-02-06
Start date
2026-02-01
Completion date
2027-02-01
Last updated
2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Respiratory Adverse Events, Postoperative Respiratory Complications

Keywords

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

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.

Interventions

OTHERUltrasonographic subglottic airway measurement

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

Sponsors

Bursa Sevket Yilmaz Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Perioperative respiratory adverse events (PRAE)immediately after the surgeryThe occurrence of clinically significant perioperative respiratory adverse events, defined as moderate to severe stridor and/or laryngospasm requiring clinical intervention, including positive pressur

Secondary

MeasureTime frameDescription
Ultrasonographic subglottic airway dimensions and areaDuring surgerySubglottic 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTGürcan Güler
gurcanguler.45@gmail.com+90 541 975 0407

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026