No DIET Trial: Dogmatic Interruption of Enteral nuTrition

Not Applicable

Recruiting

• Conditions: Tracheostomy; Gastrostomy
• Interventions: 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.

• Registration Number: NCT06431048
• Lead Sponsor: Jeffrey Coughenour

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.

Study Timeline

• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-24
• Study First Posted: 2024-05-28
• Study Start: 2024-06-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-19
• Primary Completion: 2025-06
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients receiving PEG nutrition, scheduled for tracheostomy placement.	Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure.	-
Patients receiving PEG nutrition, scheduled for tracheostomy placement.	Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure.	-
Patients receiving naso-enteral feeding, scheduled for PEG placement.	Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure.	-
Patients receiving naso-enteral feeding, scheduled for PEG placement.	Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure.	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Missouri Hospital; 🇺🇸 Columbia, Missouri, United States