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Clinical Trials/NCT07394686
NCT07394686
Not yet recruiting
Not Applicable

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

Bursa Sevket Yilmaz Training and Research Hospital1 site in 1 country350 target enrollmentStarted: February 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Bursa Sevket Yilmaz Training and Research Hospital
Enrollment
350
Locations
1
Primary Endpoint
Perioperative respiratory adverse events (PRAE)

Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
— to 3 Years (Child)
Sex
All
Accepts 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

Arms & Interventions

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.

Intervention: Ultrasonographic subglottic airway measurement (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Ultrasonographic subglottic airway dimensions and area(During surgery)

Investigators

Sponsor
Bursa Sevket Yilmaz Training and Research Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Gürcan Güler

Principal Investigator

Bursa Sevket Yilmaz Training and Research Hospital

Study Sites (1)

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