No DIET Trial: Dogmatic Interruption of Enteral nuTrition

Status

Enrolling by invitation

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06431048

Enrollment

120

Registered

2024-05-28

Start date

2024-06-25

Completion date

2027-12-31

Last updated

2025-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrostomy, Tracheostomy

Keywords

Percutaneous Endoscopic Gastrostomy, Tracheostomy, Enteral feeding

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.

Interventions

OTHERNaso-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).

OTHERNaso-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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Measuring stomach contents in patients undergoing a tracheostomy and/or PEG placement.	0-8 hours	Measurement of stomach contents will be done with enteral feeding stopped at different time points prior to undergoing the surgical procedure.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026