NCT04612348

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

February 26, 2021

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2026

Completed
4 months until next milestone

Results Posted

Study results publicly available

July 21, 2026

Completed
Last Updated

July 21, 2026

Status Verified

June 1, 2026

Enrollment Period

5.1 years

First QC Date

October 27, 2020

Results QC Date

June 22, 2026

Last Update Submit

June 22, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Average Gastric Volume

    Median volume (mL/kg) of gastric contents measured by ultrasound.

    Baseline - 5 days

Secondary Outcomes (1)

  • Risk of Aspiration

    Baseline - 5 days

Study Arms (2)

NJ tube fed

Critically ill children receiving nutrition via a nasojejunal feeding tube.

Diagnostic Test: Ultrasound

NG tube fed

Critically ill children receiving nutrition via a nasogastric feeding tube.

Diagnostic Test: Ultrasound

Interventions

UltrasoundDIAGNOSTIC_TEST

Point of care ultrasound to measure gastric contents.

NG tube fedNJ tube fed

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Joseph Tobias, MD
Organization
Nationwide Children's Hospital

Study Officials

  • Joseph D Tobias, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

March 17, 2026

Study Completion

March 17, 2026

Last Updated

July 21, 2026

Results First Posted

July 21, 2026

Record last verified: 2026-06

Locations