- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04612348
Gastric Ultrasound in Tube Fed Intubated Patients
June 18, 2025 updated by: Joseph D. Tobias
Utility of POC Gastric Ultrasound in Confirming Stomach is Empty in Intubated Patients Fed Gastrically (NG) Versus Transpylorically (NJ) to Ensure Low Risk of Aspiration.
This study will use point of care (POC) gastric ultrasound to confirm that nasojejunal tube (NJ) feeds result in minimal to no gastric content and therefore are low risk for aspiration and should be allowed at the very least to decrease the time that enteral feeds need to be held prior to a procedure or if they need to be held at all.
This would allow critically ill children to receive the nutrition that they need to heal for longer periods of time.
Using ultrasound would also potentially eliminate the need for exposure to x-rays to confirm tube placement.
Most ICUs have a POC ultrasound machine so this would be any easy tool to access to improve patient care.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
-
-
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.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Critically ill children at Nationwide Children's Hospital
Description
Inclusion Criteria:
- all PICU patients intubated < 7 days that are receiving NJ or NG feeds
Exclusion Criteria:
- patients that cannot be moved
- patients with significant GI conditions affecting motility
- patients intubated for more than seven days
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
NJ tube fed
Critically ill children receiving nutrition via a nasojejunal feeding tube.
|
Point of care ultrasound to measure gastric contents.
|
|
NG tube fed
Critically ill children receiving nutrition via a nasogastric feeding tube.
|
Point of care ultrasound to measure gastric contents.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gastric contents
Time Frame: Baseline (Day 1)
|
Amount of gastric contents measured by ultrasound.
|
Baseline (Day 1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gastric contents
Time Frame: Day 2 (if still intubated & being tube fed)
|
Amount of gastric contents measured by ultrasound.
|
Day 2 (if still intubated & being tube fed)
|
|
Gastric contents
Time Frame: Day 3 (if still intubated & being tube fed)
|
Amount of gastric contents measured by ultrasound.
|
Day 3 (if still intubated & being tube fed)
|
|
Gastric contents
Time Frame: Day 4 (if still intubated & being tube fed)
|
Amount of gastric contents measured by ultrasound.
|
Day 4 (if still intubated & being tube fed)
|
|
Gastric contents
Time Frame: Day 5 (if still intubated & being tube fed)
|
Amount of gastric contents measured by ultrasound.
|
Day 5 (if still intubated & being tube fed)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joseph D Tobias, MD, Nationwide 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 Major Dates
Study Start (Actual)
February 26, 2021
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
October 27, 2020
First Submitted That Met QC Criteria
October 27, 2020
First Posted (Actual)
November 3, 2020
Study Record Updates
Last Update Posted (Actual)
June 24, 2025
Last Update Submitted That Met QC Criteria
June 18, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00001377
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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