NCT06431048

No DIET Trial: Dogmatic Interruption of Enteral nuTrition

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Jeffrey Coughenour · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2024-06-25
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2024-05-28
• Last updated: 2025-09-26

Locations

1 site across 1 country: United States