<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03031379</url>
  </required_header>
  <id_info>
    <org_study_id>MMC-12-06-219</org_study_id>
    <nct_id>NCT03031379</nct_id>
  </id_info>
  <brief_title>Shortened Preoperative Fasts in ICU</brief_title>
  <official_title>Feasibility of Shortened Preoperative Fasts in Intubated ICU Patients Undergoing Tracheotomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montefiore Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized controlled trial assessing the safety and benefits of shortening preoperative&#xD;
      fasts on intubated ICU patients undergoing tracheotomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients undergoing bedside tracheotomy in an ICU are enrolled and randomized into two&#xD;
      groups. Arm A receive a standard fast of at least 6 hours. Arm B receive a shortened fast of&#xD;
      only 45 minutes, just before the surgery begins. Patients will be monitored for aspiration,&#xD;
      pneumonia and our ability to delivery better nutrition as a result of the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Calories delivered</measure>
    <time_frame>72 hours</time_frame>
    <description>Calories delivered before and after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Aspiration</measure>
    <time_frame>5 days</time_frame>
    <description>intraoperative or postoperative aspiration</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Intubated ICU Patients</condition>
  <arm_group>
    <arm_group_label>A - control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>standard fast, at least 6 hours prior to tracheotomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B - shortened fast</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>fast of only 45 minutes prior to incision</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>shortened fast</intervention_name>
    <description>fast of 45 minutes prior to surgery as opposed to standard 6 hour fast</description>
    <arm_group_label>B - shortened fast</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  intubated ICU patient undergoing tracheotomy, receiving enteral nutrition, adult,&#xD;
             proxy available for consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant, &lt;18yo, cannot tolerate enteral feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2012</verification_date>
  <study_first_submitted>January 22, 2017</study_first_submitted>
  <study_first_submitted_qc>January 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>April 18, 2018</last_update_submitted>
  <last_update_submitted_qc>April 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03031379
org study id: MMC-12-06-219
nct id: NCT03031379
lead sponsor: 
has dmc: Yes
Randomized controlled trial assessing the safety and benefits of shortening preoperative
      fasts on intubated ICU patients undergoing tracheotomy.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Calories delivered
time frame: 72 hours
description: Calories delivered before and after surgery
measure: Aspiration
time frame: 5 days
description: intraoperative or postoperative aspiration
arm group label: A - control
arm group type: No Intervention
description: standard fast, at least 6 hours prior to tracheotomy
arm group label: B - shortened fast
arm group type: Experimental
description: fast of only 45 minutes prior to incision
intervention type: Other
intervention name: shortened fast
description: fast of 45 minutes prior to surgery as opposed to standard 6 hour fast
arm group label: B - shortened fast
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor