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NCT Number: NCT07394686

Ultrasonographic Subglottic Airway Measurements and Postoperative Respiratory Events in Young Children

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.

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Key information

Conditions

Perioperative Respiratory Adverse Events Postoperative Respiratory Complications

Age range

Up to 3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gürcan Güler

CONTACT

[email protected]

+90 541 975 0407

Sponsors and collaborators

Lead sponsor

Bursa Sevket Yilmaz Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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