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. — OTHER
    Naso-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. — OTHER
    Naso-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)

FacilityCityStateZIPSite coordinators
University of Missouri HospitalColumbiaMissouri65212-

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