Shortened Preoperative Fasts in ICU

April 18, 2018 updated by: Montefiore Medical Center

Feasibility of Shortened Preoperative Fasts in Intubated ICU Patients Undergoing Tracheotomy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant, <18yo, cannot tolerate enteral feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: A - control
standard fast, at least 6 hours prior to tracheotomy
Experimental: B - shortened fast
fast of only 45 minutes prior to incision
Other: shortened fast
fast of 45 minutes prior to surgery as opposed to standard 6 hour fast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calories delivered
Time Frame: 72 hours
Calories delivered before and after surgery
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aspiration
Time Frame: 5 days
intraoperative or postoperative aspiration
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

January 22, 2017

First Submitted That Met QC Criteria

January 22, 2017

First Posted (Estimate)

January 25, 2017

Study Record Updates

Last Update Posted (Actual)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 18, 2018

Last Verified

February 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • MMC-12-06-219

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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