Gastric Ultrasound in Tube Fed Intubated Patients

Critical Illness Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04612348
• Other study ID #: STUDY00001377
• Status: Enrolling by invitation
• Start date: February 26, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Diagnostic Test:
• Ultrasound
Point of care ultrasound to measure gastric contents.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Joseph D. Tobias

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric contents	Amount of gastric contents measured by ultrasound.	Baseline (Day 1)
Secondary	Gastric contents	Amount of gastric contents measured by ultrasound.	Day 2 (if still intubated & being tube fed)
Secondary	Gastric contents	Amount of gastric contents measured by ultrasound.	Day 3 (if still intubated & being tube fed)
Secondary	Gastric contents	Amount of gastric contents measured by ultrasound.	Day 4 (if still intubated & being tube fed)
Secondary	Gastric contents	Amount of gastric contents measured by ultrasound.	Day 5 (if still intubated & being tube fed)