No DIET Trial: Dogmatic Interruption of Enteral nuTrition

NCT06431048 | Enrolling By Invitation

• 1 other identifier: 2101744
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrostomy; Tracheostomy

Keywords

Percutaneous Endoscopic Gastrostomy; Tracheostomy; Enteral feeding

Outcome Measures

Primary Outcomes (1)

• Measuring stomach contents in patients undergoing a tracheostomy and/or PEG placement.

  Measurement of stomach contents will be done with enteral feeding stopped at different time points prior to undergoing the surgical procedure.

  0-8 hours

Study Arms (2)

Patients receiving PEG nutrition, scheduled for tracheostomy placement.

EXPERIMENTAL

Other: Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure.; Other: Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure.

Patients receiving naso-enteral feeding, scheduled for PEG placement.

EXPERIMENTAL

Other: Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure.; Other: Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure.

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).

Patients receiving PEG nutrition, scheduled for tracheostomy placement.; Patients receiving naso-enteral feeding, scheduled for PEG placement.

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).

Patients receiving PEG nutrition, scheduled for tracheostomy placement.; Patients receiving naso-enteral feeding, scheduled for PEG placement.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged \>18 years.
• Patients who require a tracheostomy or PEG placement.

You may not qualify if:

• Patients with gastric and/or bowel obstruction.
• Patients unable to receive enteral nutrition.
• Patients who are pregnant and/or breastfeeding.

Sponsors & Collaborators

• Jeffrey Coughenour: lead

Study Sites (1)

University of Missouri Hospital

Columbia, Missouri, 65212, United States

Location

Related Publications (5)

• Glanz, S. Hold the feeds … or not? Exploring intraoperative feeding. Published online 2019:2017-2019.

  BACKGROUND

• Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.

  PMID: 28045707 BACKGROUND

• Carmichael H, Joyce S, Smith T, Patton L, Lambert Wagner A, Wiktor AJ. Safety and efficacy of intraoperative gastric feeding during burn surgery. Burns. 2019 Aug;45(5):1089-1093. doi: 10.1016/j.burns.2018.12.009. Epub 2019 Apr 1.

  PMID: 30948280 BACKGROUND

• Schneider JA, Lee YJ, Grubb WR, Denny J, Hunter C. Institutional practices of withholding enteral feeding from intubated patients. Crit Care Med. 2009 Jul;37(7):2299-302. doi: 10.1097/CCM.0b013e3181a007eb.

  PMID: 19455023 BACKGROUND

• Shahmanyan D, Lawrence JC, Lollar DI, Hamill ME, Faulks ER, Collier BR, Chestovich PJ, Bower KL. Early feeding after percutaneous endoscopic gastrostomy tube placement in patients who require trauma and surgical intensive care: A retrospective cohort study. JPEN J Parenter Enteral Nutr. 2022 Jul;46(5):1160-1166. doi: 10.1002/jpen.2303. Epub 2022 Jan 27.

  PMID: 34791680 BACKGROUND

Study Officials

• Jeffrey Coughenour, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Clinical Surgery

Model Details: The two groups per arm in this study are: 1. Nutrition will be stopped when the patient is called to the OR for scheduled procedure. 2. Nutrition will be stopped 2 hours before the scheduled procedure.

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 28, 2024
• Study Start: June 25, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)