Gastric Ultrasound in Tube Fed Intubated Patients
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.
1 other identifier
observational
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2020
CompletedFirst Posted
Study publicly available on registry
November 3, 2020
CompletedStudy Start
First participant enrolled
February 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
June 24, 2025
June 1, 2025
5.8 years
October 27, 2020
June 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Gastric contents
Amount of gastric contents measured by ultrasound.
Baseline (Day 1)
Secondary Outcomes (4)
Gastric contents
Day 2 (if still intubated & being tube fed)
Gastric contents
Day 3 (if still intubated & being tube fed)
Gastric contents
Day 4 (if still intubated & being tube fed)
Gastric contents
Day 5 (if still intubated & being tube fed)
Study Arms (2)
NJ tube fed
Critically ill children receiving nutrition via a nasojejunal feeding tube.
NG tube fed
Critically ill children receiving nutrition via a nasogastric feeding tube.
Interventions
Point of care ultrasound to measure gastric contents.
Eligibility Criteria
Critically ill children at Nationwide Children's Hospital
You may qualify if:
- all PICU patients intubated \< 7 days that are receiving NJ or NG feeds
You may not qualify if:
- patients that cannot be moved
- patients with significant GI conditions affecting motility
- patients intubated for more than seven days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Joseph D. Tobiaslead
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph D Tobias, MD
Nationwide Children's Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chair, Dept. of Anesthesiology & Pain Medicine
Study Record Dates
First Submitted
October 27, 2020
First Posted
November 3, 2020
Study Start
February 26, 2021
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
June 24, 2025
Record last verified: 2025-06