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OpenTrials
Enrolling by Invitation

NCT Number: NCT06431048

No DIET Trial: Dogmatic Interruption of Enteral nuTrition

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri Hospital

Columbia, Missouri, 65212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

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

    Time frame: 0-8 hours

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

Sponsors and collaborators

Lead sponsor

Jeffrey Coughenour

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 28, 2024
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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