Ultrasonographic Subglottic Airway Measurements and Postoperative Respiratory Events in Young Children

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 3
SponsorBursa Sevket Yilmaz Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Known congenital or acquired airway anomalies

Craniofacial anomalies

Emergency surgical procedures

Planned tracheal intubation instead of laryngeal mask airway

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ultrasonographic subglottic airway measurement

    Other intervention

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

Treatment groups

350 Participants
are divided into 1 treatment group
Group A: Pediatric patients under three years of age1 intervention

Trial outcomes

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

Time frame
immediately after the surgery

Secondary outcomes

1

Ultrasonographic subglottic airway dimensions and area

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.

Time frame
During surgery

Other outcomes

Sponsors and contacts

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