Impact of Positive End-expiratory Pressure on Stomach Contents in Children
The Effect of End-expiratory Positive Pressure on Gastric Residual Volume in Elective Pediatric Outpatient Surgery Where Laryngeal Mask is Applied
This study looks at how using positive end-expiratory pressure during surgery affects the stomach contents of children aged 1-11 years who are having outpatient procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 1 Year to 11 Years |
| Sex | All |
| Sponsor | Bakirkoy Dr. Sadi Konuk Research and Training Hospital Government |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06426394 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess how positive end-expiratory pressure affects gastric residual volume in pediatric patients undergoing outpatient surgery with laryngeal mask anesthesia. It includes children aged 1-11 years classified as ASA I-II, focusing on those undergoing lower abdominal and genitourinary procedures. The study will utilize gastric ultrasonography to monitor gastric volume at various perioperative intervals, while also evaluating the influence of this pressure on ventilator parameters and airway pressures. The variability in anesthesiologist preferences for positive end-expiratory pressure will also be taken into account.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 1-11 years undergoing elective outpatient minor surgeries with appropriate fasting periods.
Not a fit: Patients with inappropriate fasting periods, emergency surgeries, or ASA classifications of 3-4 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and management of gastric residual volume in pediatric outpatient surgeries.
How similar studies have performed: While similar studies have explored the effects of positive end-expiratory pressure, this specific approach in pediatric outpatient settings is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pediatric patients who will undergo elective outpatient minor surgery (lower abdominal and urogenital) * 1-11 years old * American Society of Anesthesiology (ASA) classification 1-2 patient groups * Patients who are fully hungry and whose fasting period is appropriate for their age and diet. Exclusion Criteria: * Patients whose fasting period is not appropriate * Acute abdominal and emergency surgeries * ASA 3-4 patient group * Patients with diseases or medication use that will affect gastric emptying time * Previous nasogastric tube placement and re-operation • Patients with known difficult airway or failure to fit the laryngeal mask
Where this trial is running
Istanbul
- Duygu Akyol — Istanbul, Turkey (Recruiting)
Study contacts
- Study coordinator: Duygu Akyol, M.d
- Email: dr.duyguaygun@gmail.com
- Phone: +905447616034
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.