Shortened Preoperative Fasts in ICU

NCT ID: NCT03031379

Last Updated: 2018-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-04-30

Brief Summary

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

Detailed Description

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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

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Intubated ICU Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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A - control

standard fast, at least 6 hours prior to tracheotomy

Group Type NO_INTERVENTION

No interventions assigned to this group

B - shortened fast

fast of only 45 minutes prior to incision

Group Type EXPERIMENTAL

shortened fast

Intervention Type OTHER

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

Interventions

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shortened fast

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnant, \<18yo, cannot tolerate enteral feeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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MMC-12-06-219

Identifier Type: -

Identifier Source: org_study_id

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