No DIET Trial: Dogmatic Interruption of Enteral nuTrition

Gastrostomy Clinical Trial

Official title:

No DIET Trial: Dogmatic Interruption of Enteral nuTrition

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06431048
• Other study ID #: 2101744
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: University of Missouri-Columbia
• Contact: Antoinette Burger, PhD
• Phone: 5738843740
• Email: aburger[@]health.missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrostomy
• Tracheostomy

Intervention

Other:
• Nutrition will not be stopped preoperatively, but in the operating room (OR) for scheduled procedure.
Nutrition will not be stopped preoperatively, but in the operating room (OR) for scheduled procedure.
• Nutrition will be stopped when the patient is called to the OR for scheduled procedure.
Nutrition will be stopped when the patient is called to the OR for scheduled procedure.
• Nutrition will be stopped 4 hours before the scheduled procedure.
Nutrition will be stopped 4 hours before the scheduled procedure.
• Nutrition will be stopped 6 hours before the scheduled procedure.
Nutrition will be stopped 6 hours before the scheduled procedure.
• Nutrition will be stopped 8 hours before the scheduled procedure.
Nutrition will be stopped 8 hours before the scheduled procedure.

Locations

Country	Name	City	State
United States	University of Missouri Hospital	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Jeffrey Coughenour

Country where clinical trial is conducted

United States, 

Outcome

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