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Completed

NCT Number: NCT03031379

Shortened Preoperative Fasts in ICU

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

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Key information

Conditions

Intubated ICU Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • pregnant, <18yo, cannot tolerate enteral feeding

Treatment and study plan

shortened fast

Other

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

Primary outcomes

  1. Calories delivered

    Time frame: 72 hours

    Calories delivered before and after surgery

Secondary outcomes

  1. Aspiration

    Time frame: 5 days

    intraoperative or postoperative aspiration

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Feasibility of Shortened Preoperative Fasts in Intubated ICU Patients Undergoing Tracheotomy

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 25, 2017
Registry last updated
Apr 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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