Gastric Ultrasound in Tube Fed Intubated Patients

• Sponsor: Joseph D. Tobias (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04612348
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 34.1
• Patients Per Site Per Month: 5.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness	Diagnostic Test: Ultrasound

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• 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.
• Actual Study Start Date: Feb 26, 2021
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
NJ tube fed Critically ill children receiving nutrition via a nasojejunal feeding tube.	Diagnostic Test: Ultrasound; Point of care ultrasound to measure gastric contents.
NG tube fed Critically ill children receiving nutrition via a nasogastric feeding tube.	Diagnostic Test: Ultrasound; Point of care ultrasound to measure gastric contents.

Outcome Measures

Primary Outcome Measures

1. Gastric contents [Baseline (Day 1)]

   Amount of gastric contents measured by ultrasound.

Secondary Outcome Measures

1. Gastric contents [Day 2 (if still intubated & being tube fed)]

   Amount of gastric contents measured by ultrasound.

2. Gastric contents [Day 3 (if still intubated & being tube fed)]

   Amount of gastric contents measured by ultrasound.

3. Gastric contents [Day 4 (if still intubated & being tube fed)]

   Amount of gastric contents measured by ultrasound.

4. Gastric contents [Day 5 (if still intubated & being tube fed)]

   Amount of gastric contents measured by ultrasound.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205

Sponsors and Collaborators

• Joseph D. Tobias

Investigators

• Principal Investigator: Joseph D Tobias, MD, Nationwide Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joseph D. Tobias, Chair, Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
• ClinicalTrials.gov Identifier: NCT04612348
• Other Study ID Numbers: STUDY00001377
• First Posted: Nov 3, 2020
• Last Update Posted: Apr 12, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Critical Illness

Study Results

No Results Posted as of Apr 12, 2022