No DIET Trial: Dogmatic Interruption of Enteral nuTrition

NCT ID: NCT06431048

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-25
• Study Completion Date: 2027-12-31

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.

Detailed Description

The risk for malnutrition-associated complications is high for patients in the trauma- surgical-, and neurological intensive care units. Patients with persistent neurologic impairment often require nutritional supplementation through a variety of naso-enteral or surgical feeding tubes such as percutaneous endoscopic gastrostomy (PEG) tubes. In patients with a protected airway, enteral nutrition has been reported to continue during invasive surgical procedures. Nonetheless, University Hospital's current SOC for holding enteral nutrition prior to undergoing surgical procedures under anesthesia is 8 hours. However, the current American Society of Anesthesiologists (ASA) guidelines do not make provision for inpatients receiving supplemental enteral nutrition. Enteral nutrition contains protein, fat, and carbohydrates, mimicking what patients would consume with a solid food meal. Balancing the need of optimized nutrition in critically ill patients with an unprotected airway against the risk of aspiration during surgical procedures brings a need for clear guidance on when to hold enteral nutrition prior to undergoing a tracheostomy procedure.

Conditions

Gastrostomy; Tracheostomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patients receiving PEG nutrition, scheduled for tracheostomy placement.

Group Type: EXPERIMENTAL

Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure.

Intervention Type: 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.

Intervention Type: OTHER

Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure (tracheostomy + PEG or PEG only).

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

Group Type: EXPERIMENTAL

Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure.

Intervention Type: 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.

Intervention Type: OTHER

Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure (tracheostomy + PEG or PEG only).

Interventions

Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure.

Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure (tracheostomy + PEG or PEG only).

Intervention Type: OTHER

Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure.

Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure (tracheostomy + PEG or PEG only).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jeffrey Coughenour

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Coughenour

Associate Professor of Clinical Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jeffrey Coughenour, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri Hospital

Columbia, Missouri, United States

Countries

United States

References

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 28045707 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30948280 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19455023 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34791680 (View on PubMed)

Other Identifiers

2101744

Identifier Type: -

Identifier Source: org_study_id