## Protocol Section
### Identification Module
**NCT ID:** NCT06431048

**Brief Title:** No DIET Trial: Dogmatic Interruption of Enteral nuTrition

**Official Title:** No DIET Trial: Dogmatic Interruption of Enteral nuTrition

#### Organization Study ID Info
**ID:** 2101744
#### Organization
**Class:** OTHER
**Full Name:** University of Missouri-Columbia
### Status Module
#### Completion Date
**Date:** 2025-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Jeffrey Coughenour

#### Responsible Party

**Investigator Affiliation:** University of Missouri-Columbia

**Investigator Full Name:** Jeffrey Coughenour

**Investigator Title:** Associate Professor of Clinical Surgery

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Gastrostomy

- Tracheostomy

**Keywords:**

- Percutaneous Endoscopic Gastrostomy

- Tracheostomy

- Enteral feeding

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** The five groups per arm in this study are:

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

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Nutrition will not be stopped preoperatively, but in the operating room (OR) for scheduled procedure.

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

- Other: Nutrition will be stopped 4 hours before the scheduled procedure.

- Other: Nutrition will be stopped 6 hours before the scheduled procedure.

- Other: Nutrition will be stopped 8 hours before the scheduled procedure.

**Label:** Patients receiving PEG nutrition, scheduled for tracheostomy placement.

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Other: Nutrition will not be stopped preoperatively, but in the operating room (OR) for scheduled procedure.

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

- Other: Nutrition will be stopped 4 hours before the scheduled procedure.

- Other: Nutrition will be stopped 6 hours before the scheduled procedure.

- Other: Nutrition will be stopped 8 hours before the scheduled procedure.

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

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients receiving PEG nutrition, scheduled for tracheostomy placement.

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

**Description:** Nutrition will not be stopped preoperatively, but in the operating room (OR) for scheduled procedure.

**Name:** Nutrition will not be stopped preoperatively, but in the operating room (OR) for scheduled procedure.

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Patients receiving PEG nutrition, scheduled for tracheostomy placement.

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

**Description:** Nutrition will be stopped when the patient is called to the OR for scheduled procedure.

**Name:** Nutrition will be stopped when the patient is called to the OR for scheduled procedure.

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Patients receiving PEG nutrition, scheduled for tracheostomy placement.

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

**Description:** Nutrition will be stopped 4 hours before the scheduled procedure.

**Name:** Nutrition will be stopped 4 hours before the scheduled procedure.

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Patients receiving PEG nutrition, scheduled for tracheostomy placement.

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

**Description:** Nutrition will be stopped 6 hours before the scheduled procedure.

**Name:** Nutrition will be stopped 6 hours before the scheduled procedure.

**Type:** OTHER

#### Intervention 5

**Arm Group Labels:**

- Patients receiving PEG nutrition, scheduled for tracheostomy placement.

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

**Description:** Nutrition will be stopped 8 hours before the scheduled procedure.

**Name:** Nutrition will be stopped 8 hours before the scheduled procedure.

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Measurement of stomach contents will be done with enteral feeding stopped at different time points prior to undergoing the surgical procedure.

**Measure:** Measuring stomach contents in patients undergoing a tracheostomy and/or PEG placement.

**Time Frame:** 0-8 hours

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** aburger@health.missouri.edu

**Name:** Antoinette Burger, PhD

**Phone:** 5738843740

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Columbia

**Contacts:**

***Contact 1:***

- **Email:** aburger@health.missouri.edu

- **Name:** Antoinette Burger, PhD

- **Phone:** 573-884-3740

- **Role:** CONTACT

***Contact 2:***

- **Name:** Jeffrey Coughenour, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Patrick Ward, DO

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** University of Missouri Hospital

**State:** Missouri

**Zip:** 65212

#### Overall Officials

**Official 1:**

**Affiliation:** University of Missouri-Columbia

**Name:** Jeffrey Coughenour, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
