No DIET Trial: Dogmatic Interruption of Enteral nuTrition

Jeffrey Coughenour

Status: Invitation-only

Conditions: Tracheostomy; Gastrostomy

Treatments: Other: Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure.; Other: Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure.

Study type: Interventional

Funder types: Other

Identifiers

NCT06431048

2101744

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Patients receiving PEG nutrition, scheduled for tracheostomy placement.

Experimental group

Treatment:

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

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

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

Experimental group

Treatment:

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

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