RECRUITING

Gastric Assessment of Pediatric Patients Undergoing Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this pilot prospective cohort study is to examine the reproducibility of gastric volume and emptying as measured by gastric ultrasound and its correlation to a gold-standard test for gastric emptying in the perioperative period in pediatric patients. The main questions it aims to answer are: * What is the reliability (inter-rater variability between expert and novice assessors, and intra-rater variability) of a) the gastric antral cross-sectional area (CSA) and b) gastric volume using the Perlas US qualitative grading assessment, measured by using an ultrasound device in pediatric patients undergoing general anesthesia for elective surgery? * What is the correlation between ultrasound assessment of gastric emptying by the antral-CSA and gastric emptying determined by the acetaminophen absorption test (AAT), the gold standard? The study will include two cohorts. Cohort assignment will be based on age and anesthesia induction plan. Subjects \>7yrs of age and expected to get an IV induction will be assigned to Cohort #1. Subjects \<7yrs of age and not expected to get an IV induction will be assigned to Cohort #2. * Cohort 1 will include abdominal ultrasound for gastric assessment AND the acetaminophen absorption test which includes administering enteral acetaminophen (tylenol) with 6 oz of water and drawing of blood samples through a peripheral intravenous line. * Cohort 2 will include subjects for whom a peripheral intravenous line placement is not part of routine pre-operative care. Procedures for Cohort 2 will include abdominal ultrasound only in the pre-op area (no tylenol). This cohort is included to examine the reliability of measurements across age groups.

Official Title

Gastric Assessment of Pediatric Patients Undergoing Surgery

Quick Facts

Study Start:2023-02-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05674643

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Perioperative patients with ASA classification 1-2
  2. * Ages: 2 years- less than 18 years
  3. * Locations: Longwood and Waltham campuses of Boston Childrens Hospital
  1. * History of gastrointestinal surgery
  2. * Gastrostomy
  3. * Known GI dysmotility (cohort 1 only)
  4. * Acetaminophen allergy (cohort 1 only)
  5. * 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)
  6. * Consumption of acetaminophen in the 4 hours prior (cohort 1 only)

Contacts and Locations

Study Contact

Jocelyn Booth, BSN
CONTACT
857-218-4585
jocelyn.booth@childrens.harvard.edu
Rachel Bernier, MPH
CONTACT
857-218-5348
rachel.bernier@childrens.harvard.edu

Study Locations (Sites)

Boston Children's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-02-01
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • gastric ultrasound
  • pre-operative fasting

Additional Relevant MeSH Terms

  • Fasting
  • Delayed Gastric Emptying
  • Aspiration Pneumonia
  • Respiratory Aspiration of Gastric Content