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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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04612348
Enrollment
45
Registered
2020-11-03
Start date
2021-02-26
Completion date
2026-03-17
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

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.

Interventions

DIAGNOSTIC_TESTUltrasound

Point of care ultrasound to measure gastric contents.

Sponsors

Joseph D. Tobias
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Average Gastric VolumeBaseline - 5 daysMedian volume (mL/kg) of gastric contents measured by ultrasound.

Secondary

MeasureTime frameDescription
Risk of AspirationBaseline - 5 daysThe potential risk of aspirating stomach contents if patient underwent intubation.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJoseph D Tobias, MD

Nationwide Children's Hospital

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
45 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous12 months
Height76.1 centimeters
PRISM
Low risk
8 Participants
PRISM
Moderate risk
5 Participants
PRISM
Unknown
3 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
16 participants
Sex: Female, Male
Female
7 Participants
Sex: Female, Male
Male
22 Participants
Weight7.9 kilograms

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 160 / 29
other
Total, other adverse events
0 / 160 / 29
serious
Total, serious adverse events
0 / 160 / 29

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026