Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting study of Fasting and Aspiration Pneumonia, sponsored by Boston Children's Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measured using the following quantitative and qualitative ultrasound assessments between a novice and an expert gastric ultrasound operator: * Qualitative using the previously published Perlas' US qualitative grading assessment * Grade 0- no contents visualized in supine and lateral position * Grade 1- contents visualized in the lateral decubitus position (RLD) only * Grade 2- contents visualized in the supine and RLD. * Quantitative assessment using the cross-sectional area as published by Spe
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 |
What NCT05674643 shows while recruiting
NCT05674643 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 202-participant average among 8 other Fasting trials with a reported enrollment target (70% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Fasting
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05674643's enrollment target sits among peer trials
60 4th of 8 higher than 5 of 8 other Fasting trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fasting trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Preoperative Fasting vs. Not Fasting in Critically Ill Patients
RECRUITING · NA
-
Immunomodulatory Effects of Fasting in Healthy Adults
RECRUITING · NA
-
Effect of Fasting on Patient Outcomes After Wide-Awake, Local Anesthesia-only, No Tourniquet (WALANT) Procedures
RECRUITING · NA
-
Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume
RECRUITING · NA
-
Fastomics: Metabolic and Therapeutic Effects of Prolonged Fasting
RECRUITING
-
Regulation of FGF21 by Nutritional Challenges
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00576069 · 60 participants
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- NCT01297400 · 60 participants · Phase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- NCT01734122 · 60 participants
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
- NCT01804634 · 60 participants · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI