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Shortened Preoperative Fasts in ICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03031379
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : April 20, 2018
Information provided by (Responsible Party):
Montefiore Medical Center

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

Condition or disease Intervention/treatment Phase
Intubated ICU Patients Other: shortened fast Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility of Shortened Preoperative Fasts in Intubated ICU Patients Undergoing Tracheotomy
Study Start Date : April 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

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

Primary Outcome Measures :
  1. Calories delivered [ Time Frame: 72 hours ]
    Calories delivered before and after surgery

Secondary Outcome Measures :
  1. Aspiration [ Time Frame: 5 days ]
    intraoperative or postoperative aspiration

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant, <18yo, cannot tolerate enteral feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03031379

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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
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Responsible Party: Montefiore Medical Center Identifier: NCT03031379    
Other Study ID Numbers: MMC-12-06-219
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: February 2012