No DIET Trial: Dogmatic Interruption of Enteral nuTrition
Part of paid clinical trials in Columbia, Missouri.
- Sponsor
- Jeffrey Coughenour
- Study ID
- NCT06431048
- Status
- Enrolling By Invitation
Conditions
- Gastrostomy
- Tracheostomy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure. — OTHERNaso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure (tracheostomy + PEG or PEG only).
- Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure. — OTHERNaso-enteral nutrition will be stopped 2 hours before the scheduled procedure (tracheostomy + PEG or PEG only).
Study Details
There is currently limited guidance on when to hold nutritional supplementation through for patients, who are receiving tube feeding, undergoing surgical procedures. This study aims to investigate which time would be the best to stop nutrition, if at all, before undergoing a surgical procedure.
Key Dates
- Start date
- Jun 25, 2024
- Status verified
- Sep 2025
- Primary completion
- Jun 30, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 120 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Patients receiving PEG nutrition, scheduled for tracheostomy placement.
- Experimental: Patients receiving naso-enteral feeding, scheduled for PEG placement.
Primary Outcome Measure
Measuring stomach contents in patients undergoing a tracheostomy and/or PEG placement. [ Time Frame: 0-8 hours ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Missouri Hospital | Columbia | Missouri | 65212 | - |
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