## Protocol Section
### Identification Module
**NCT ID:** NCT03031379

**Brief Title:** Shortened Preoperative Fasts in ICU

**Official Title:** Feasibility of Shortened Preoperative Fasts in Intubated ICU Patients Undergoing Tracheotomy

#### Organization Study ID Info
**ID:** MMC-12-06-219
#### Organization
**Class:** OTHER
**Full Name:** Montefiore Medical Center
### Status Module
#### Completion Date
**Date:** 2014-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-04-20

**Type:** ACTUAL

**Last Update Submit Date:** 2018-04-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-04

**Type:** ACTUAL

#### Start Date
**Date:** 2012-04

**Status Verified Date:** 2012-02

#### Study First Post Date
**Date:** 2017-01-25
**Type:** ESTIMATED
**Study First Submit Date:** 2017-01-22
**Study First Submit QC Date:** 2017-01-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Montefiore Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Randomized controlled trial assessing the safety and benefits of shortening preoperative fasts on intubated ICU patients undergoing tracheotomy.

**Detailed Description:** Patients undergoing bedside tracheotomy in an ICU are enrolled and randomized into two groups. Arm A receive a standard fast of at least 6 hours. Arm B receive a shortened fast of only 45 minutes, just before the surgery begins. Patients will be monitored for aspiration, pneumonia and our ability to delivery better nutrition as a result of the intervention.

### Conditions Module

**Conditions:**

- Intubated ICU Patients

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 24

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** standard fast, at least 6 hours prior to tracheotomy

**Label:** A - control

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** fast of only 45 minutes prior to incision

**Intervention Names:**

- Other: shortened fast

**Label:** B - shortened fast

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- B - shortened fast

**Description:** fast of 45 minutes prior to surgery as opposed to standard 6 hour fast

**Name:** shortened fast

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Calories delivered before and after surgery

**Measure:** Calories delivered

**Time Frame:** 72 hours

#### Secondary Outcomes

**Description:** intraoperative or postoperative aspiration

**Measure:** Aspiration

**Time Frame:** 5 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* intubated ICU patient undergoing tracheotomy, receiving enteral nutrition, adult, proxy available for consent

Exclusion Criteria:

* pregnant, \<18yo, cannot tolerate enteral feeding

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bronx

**Country:** United States

**Facility:** Montefiore Medical Center

**State:** New York

**Zip:** 10467

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
