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NCT05674643 · ClinicalTrials.gov registry record
Gastric Assessment of Pediatric Patients Undergoing Surgery
A clinical trial of Fasting and Aspiration Pneumonia, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- 60
- Enrollment target
- 1
- Study location
NCT05674643 is a study of Fasting and Aspiration Pneumonia that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 60 participants, below the 202-participant average among 8 other Fasting trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05674643, a study of Fasting and Aspiration Pneumonia, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Gastric Ultrasound Baseline Scans
- DIAGNOSTIC_TEST Acetaminophen Absorption Test (AAT)
- DIAGNOSTIC_TEST Gastric Ultrasound Serial Scans
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-02-01 |
| Est. Completion | 2024-12-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05674643
The ClinicalTrials.gov registry entry for NCT05674643 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 202-participant average among 8 other Fasting trials with a reported enrollment target (70% lower). The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Fasting appearing as the primary indexed condition, and to 3 interventions - of which Gastric Ultrasound Baseline Scans is the first listed.
NCT05674643 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05674643 about?
NCT05674643 is a clinical study titled "Gastric Assessment of Pediatric Patients Undergoing Surgery". 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 ...
What is the current status of trial NCT05674643?
This trial is currently recruiting. The enrollment target is 60 participants. The study started on 2023-02-01. Estimated completion is 2024-12-31.
What conditions does trial NCT05674643 study?
This clinical trial studies the following conditions: Fasting, Aspiration Pneumonia, Delayed Gastric Emptying, Respiratory Aspiration of Gastric Content.
What interventions are being tested in trial NCT05674643?
The interventions under investigation include: Gastric Ultrasound Baseline Scans (DIAGNOSTIC_TEST), Acetaminophen Absorption Test (AAT) (DIAGNOSTIC_TEST), Gastric Ultrasound Serial Scans (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05674643?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05674643 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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