About this trial
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
This trial does not accept healthy volunteersQualifiers
1-10 years of age
Adherence to standard preoperative fasting guidelines
Elective surgeries
ASA I-III status
Disqualifiers
Gastrointestinal tract surgeries
Laparoscopic surgeries
Emergency procedures
Full stomach patients
Trial population
Pediatric patients (1-10 years) undergoing elective surgery
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Comparison of gastric volume changes smong study groups
The primary outcome is to compare the change in gastric volume calculated via ultrasound at T0 (before induction), T1 (after the airway secured), and T2 (end of the operation) among the three groups (Endotracheal tube, first-generation SAD, and second-generation SAD). This will determine whether the choice of airway device leads to a difference in gastric volume during the perioperative period.
Secondary outcomes
Correlation between duration of surgery and change in gastric volume
Total duration of the surgical procedure and the change in gastric volume
Antral cross sectional area changes
Meauserement of antral cross sectional area at T0, T1 and T2 on lateral decubitis position
Air leakege
Air leakage percentage with different airway devices
Airway pressures
Peak airway pressures during surgery duration
Sponsors and contacts
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