Assessing gastric volume and emptying in pediatric surgery patients
Gastric Assessment of Pediatric Patients Undergoing Surgery
This study tests if using ultrasound to measure stomach size and how quickly it empties is reliable for kids having surgery, compared to a standard test, to help keep them safe during anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05674643 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the reliability of gastric ultrasound in measuring gastric volume and emptying in pediatric patients undergoing elective surgery. It will compare ultrasound assessments with the acetaminophen absorption test, a gold-standard method for determining gastric emptying. The study will include two cohorts based on age and anesthesia induction plans, focusing on inter-rater and intra-rater variability in ultrasound measurements. The goal is to enhance pre-operative assessments and improve patient safety during anesthesia.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 2 to less than 18 years with ASA classification 1-2 undergoing elective surgery.
Not a fit: Patients with a history of gastrointestinal surgery, known GI dysmotility, or those allergic to acetaminophen may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pre-operative assessments, reducing the risk of aspiration pneumonia in pediatric patients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using ultrasound for gastric assessments, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Perioperative patients with ASA classification 1-2 * Ages: 2 years- less than 18 years * Locations: Longwood and Waltham campuses of Boston Childrens Hospital Exclusion Criteria: * History of gastrointestinal surgery * Gastrostomy * Known GI dysmotility (cohort 1 only) * Acetaminophen allergy (cohort 1 only) * Liver or renal dysfunction- pre-diagnosed or, if available, when serum biomarkers are 2 standard deviations above the highest value considered normal for age. (cohort 1 only) * Consumption of acetaminophen in the 4 hours prior (cohort 1 only)
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Jocelyn Booth, BSN
- Email: jocelyn.booth@childrens.harvard.edu
- Phone: 857-218-4585
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.