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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Ultrasonographic subglottic airway measurement
Other interventionNon-invasive ultrasonographic measurement of the subglottic airway performed intraoperatively as part of routine clinical care. No therapeutic intervention is applied.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
Sponsors and contacts
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