Clinical trial NCT05674643: Gastric Assessment of Pediatric Patients Undergoing Surgery
Official title: Gastric Assessment of Pediatric Patients Undergoing Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fasting
Delayed Gastric Emptying
Aspiration Pneumonia
Respiratory Aspiration of Gastric Content
Keywords: gastric ultrasound
pre-operative fasting
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is enrolling healthy pediatric subjects ages 2 through 17 years of age who are undergoing surgery with anesthesia at Boston Children's Hospital.

Brief summary: 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.


Eligibility 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)

Primary outcomes:
measure: Inter-rater reliability
timeFrame: 1 year
measure: Intra-rater reliability
timeFrame: 1 year
measure: Gastric Emptying
timeFrame: 1 year
Secondary outcomes:
measure: Post-anesthetic outcomes
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
citation: Spencer AO, Walker AM, Yeung AK, Lardner DR, Yee K, Mulvey JM, Perlas A. Ultrasound assessment of gastric volume in the fasted pediatric patient undergoing upper gastrointestinal endoscopy: development of a predictive model using endoscopically suctioned volumes. Paediatr Anaesth. 2015 Mar;25(3):301-8. doi: 10.1111/pan.12581. Epub 2014 Dec 11.