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.

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

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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