Gastric Assessment of Pediatric Patients Undergoing Surgery

RecruitingOBSERVATIONAL
Enrollment

60

Participants

Timeline

Start Date

February 1, 2023

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
FastingDelayed Gastric EmptyingAspiration PneumoniaRespiratory Aspiration of Gastric Content
Interventions
DIAGNOSTIC_TEST

Gastric Ultrasound Baseline Scans

The patient's abdomen will be scanned using the ultrasound device by an expert scanner and novice scanner for baseline assessment of the antral CSA and gastric volume using Perlas US qualitative grading assessment.

DIAGNOSTIC_TEST

Acetaminophen Absorption Test (AAT)

"Prior to starting the AAT, a baseline plasma acetaminophen level (250 microliters) will be obtained from the intravenous catheter. The subject will then be given 12.5 mg/kg or max 650mg of single batch 32mg/mL acetaminophen followed by 6oz of water PO. Up to 3 additional small volume blood samples will be drawn for acetaminophen levels.~These additional blood samples (250 microliters each) will be obtained to measure acetaminophen plasma levels at the following goal intervals after acetaminophen administration.T1:10-20 mins, T2:35-45 mins, T3: 60mins. At the time of each lab draw gastric ultrasound will be assessed by the expert scanner to correlate gastric ultrasound with the acetaminophen absorption test as a gold-standard of gastric emptying."

DIAGNOSTIC_TEST

Gastric Ultrasound Serial Scans

Cohort 1 will have multiple scans as part of assessing gastric emptying. These sequential scans after the baseline assessment will be done in line with the Acetaminophen Absorption Test timeline (T1:10-20 mins, T2:35-45 mins, T3: 60mins) and will be performed by an expert scanner only.

Trial Locations (1)

02115

RECRUITING

Boston Children's Hospital, Boston

All Listed Sponsors
lead

Boston Children's Hospital

OTHER