Clinical trial NCT06431048: No DIET Trial: Dogmatic Interruption of Enteral NuTrition
Official title: No DIET Trial: Dogmatic Interruption of Enteral NuTrition
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Gastrostomy
Tracheostomy
Keywords: Percutaneous Endoscopic Gastrostomy
Tracheostomy
Enteral feeding
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measuring stomach contents in patients undergoing a tracheostomy and/or PEG placement.
timeFrame: 0-8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Hospital
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Jeffrey Coughenour, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Glanz, S. Hold the feeds … or not? Exploring intraoperative feeding. Published online 2019:2017-2019.
citation: Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
citation: Carmichael H, Joyce S, Smith T, Patton L, Lambert Wagner A, Wiktor AJ. Safety and efficacy of intraoperative gastric feeding during burn surgery. Burns. 2019 Aug;45(5):1089-1093. doi: 10.1016/j.burns.2018.12.009. Epub 2019 Apr 1.
citation: Schneider JA, Lee YJ, Grubb WR, Denny J, Hunter C. Institutional practices of withholding enteral feeding from intubated patients. Crit Care Med. 2009 Jul;37(7):2299-302. doi: 10.1097/CCM.0b013e3181a007eb.
citation: Shahmanyan D, Lawrence JC, Lollar DI, Hamill ME, Faulks ER, Collier BR, Chestovich PJ, Bower KL. Early feeding after percutaneous endoscopic gastrostomy tube placement in patients who require trauma and surgical intensive care: A retrospective cohort study. JPEN J Parenter Enteral Nutr. 2022 Jul;46(5):1160-1166. doi: 10.1002/jpen.2303. Epub 2022 Jan 27.