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Not Yet Recruiting NCT07555080

Comparison of Gastric Volume Changes After Ventilation With Endotracheal Tube, First-Generation Supraglottic Airway, and Second-Generation Supraglottic Airway in Pediatric Patients

Conditions: Gastric Ultrasonography, Supraglottic Airways, Supraglottic Airway Use in Children, Gastric Volume, Gastric Insufflation, Airway Complications

Sex: All
Ages: 1 Year – 10 Years
Healthy volunteers: No
Enrollment: 250
Sponsor: Istanbul University

Location: Istanbul University Istanbul

Summary

This study aims to compare the gastric volumes of pediatric patients undergoing positive-pressure ventilation with different airway management techniques. Gastric ultrasound is a non-invasive bedside tool with high sensitivity and specificity for determining the nature and amount of gastric content. In pediatric cases, maintaining a gastric volume below 1.25 mL/kg is associated with a lower risk of perioperative aspiration. Although supraglottic airway devices (SADs) are commonly used as alternatives to endotracheal tubes, concerns regarding the potential for gastric insufflation and subsequent aspiration persist. Second-generation SADs were specifically designed with gastric drainage channels to mitigate the risk of regurgitation compared to first-generation devices. The primary objective of this study is to determine whether there is a difference in gastric volumes, as measured by ultrasound, among three groups of pediatric patients: those managed with endotracheal tubes, first-generation SADs, and second-generation SADs. By comparing these measurements post-ventilation, the investigators aim to evaluate the impact of the airway device choice on gastric volume under clinical conditions.

Eligibility Criteria

Inclusion Criteria: * 1-10 years of age * Adherence to standard preoperative fasting guidelines * Elective surgeries * ASA I-III status * Surgery time 30 min to 2 hours Exclusion Criteria: * Gastrointestinal tract surgeries * Laparoscopic surgeries * Emergency procedures * Full stomach patients * Lack of parental/guardian consent

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07555080). StuddyBuddy aggregates publicly available trial information.