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Enrolling by invitation NCT06431048

No DIET Trial: Dogmatic Interruption of Enteral nuTrition

No phase Interventional Gastrostomy Tracheostomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure., Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure..
Who it may be relevant to
Registry conditions: Gastrostomy, Tracheostomy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other 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).
  • 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).

Primary outcome measures

  • Measuring stomach contents in patients undergoing a tracheostomy and/or PEG placement. [Time frame: 0-8 hours]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Missouri Hospital — Columbia

Publications

  • Glanz, S. Hold the feeds … or not? Exploring intraoperative feeding. Published online 2019:2017-2019.
  • 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):3 PMID 28045707
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06431048 · 2101744

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗