<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/NCT03277118</url>
  </required_header>
  <id_info>
    <org_study_id>STU 032017-102</org_study_id>
    <nct_id>NCT03277118</nct_id>
  </id_info>
  <brief_title>Quantifying Activity Using Wireless Wearable Technology</brief_title>
  <official_title>Quantifying Activity After Cardiac Surgery Using Wireless Wearable Technology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Wireless wearable devices (WWD) have been shown to be an effective means to measure patient&#xD;
      activity and sleep-wake cycles in the ICU. However, no current studies involving WWD have&#xD;
      demonstrated the ability of these devices to measure adverse outcomes, including delirium in&#xD;
      critically ill patients. This study is unique because the investigators will implement&#xD;
      monitoring with the WWD prior to extubation in the ICU to correctly measure first&#xD;
      mobilization, as well as capture quality of sleep and episodes of delirium for the first five&#xD;
      postoperative days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this single-center non-randomized prospective cohort study, cardiac surgical patients&#xD;
      undergoing cardiac surgery with cardiopulmonary bypass will be enrolled consecutively with&#xD;
      written informed consent from the time this protocol is approved by the IRB until 100&#xD;
      subjects are enrolled (expected duration of subject enrollment is 12 months). Upon arrival&#xD;
      into the ICU, cardiac surgery subjects will have a Fitbit Charge 2 device placed on their&#xD;
      wrist and will wear the device until the fifth post-operative day. This device will&#xD;
      wirelessly transmit data regarding activity and sleep quality to a smartphone application for&#xD;
      the duration of wear. No identifiable patient information will be entered into the smartphone&#xD;
      application or transmitted to any external entity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 18, 2017</start_date>
  <completion_date type="Actual">August 18, 2019</completion_date>
  <primary_completion_date type="Actual">August 18, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of steps walked</measure>
    <time_frame>Postoperative day 2 to Postoperative day 5</time_frame>
    <description>Number of steps walked as measured by the Wireless Wearable Device</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of sleep</measure>
    <time_frame>Postoperative Day 1</time_frame>
    <description>Number of hours slept with little activity as measured by the Wireless Wearable Device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delirium</measure>
    <time_frame>Postoperative Day 2 (after extubation)</time_frame>
    <description>Occurrence of delirium with few hours slept as measured by the Wireless Wearable Device</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">91</enrollment>
  <condition>Activity, Motor</condition>
  <condition>Sleep</condition>
  <condition>Delirium</condition>
  <arm_group>
    <arm_group_label>Cardiac Surgery Cohort</arm_group_label>
    <description>Patients aged 18 years or older who are scheduled to undergo elective cardiac surgery with cardiopulmonary bypass.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Wireless Wearable Device</intervention_name>
    <description>Wireless Wearable Device will be placed on the wrist of the patient prior to extubation in the ICU to record patient activity in terms of steps and sleep quality.</description>
    <arm_group_label>Cardiac Surgery Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients aged 18 years or older who are scheduled to undergo elective cardiac surgery at UT&#xD;
        Southwestern Medical Center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion Criteria: Adult (Age &gt; 18) patients undergoing scheduled, elective cardiac&#xD;
             surgery with cardiopulmonary bypass&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who do not meet the inclusion criteria, pregnant women, prisoners, those with&#xD;
             skin or systemic infections, those who are paraplegic or quadriplegic and those with&#xD;
             allergies to the polyurethane material comprising the FitBit strap.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sreekanth Cheruku, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>May 17, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>October 2, 2019</last_update_submitted>
  <last_update_submitted_qc>October 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Sreekanth Cheruku</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03277118
org study id: STU 032017-102
nct id: NCT03277118
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Wireless wearable devices (WWD) have been shown to be an effective means to measure patient
      activity and sleep-wake cycles in the ICU. However, no current studies involving WWD have
      demonstrated the ability of these devices to measure adverse outcomes, including delirium in
      critically ill patients. This study is unique because the investigators will implement
      monitoring with the WWD prior to extubation in the ICU to correctly measure first
      mobilization, as well as capture quality of sleep and episodes of delirium for the first five
      postoperative days.
In this single-center non-randomized prospective cohort study, cardiac surgical patients
      undergoing cardiac surgery with cardiopulmonary bypass will be enrolled consecutively with
      written informed consent from the time this protocol is approved by the IRB until 100
      subjects are enrolled (expected duration of subject enrollment is 12 months). Upon arrival
      into the ICU, cardiac surgery subjects will have a Fitbit Charge 2 device placed on their
      wrist and will wear the device until the fifth post-operative day. This device will
      wirelessly transmit data regarding activity and sleep quality to a smartphone application for
      the duration of wear. No identifiable patient information will be entered into the smartphone
      application or transmitted to any external entity.
observational model: Cohort
time perspective: Prospective
measure: Number of steps walked
time frame: Postoperative day 2 to Postoperative day 5
description: Number of steps walked as measured by the Wireless Wearable Device
measure: Length of sleep
time frame: Postoperative Day 1
description: Number of hours slept with little activity as measured by the Wireless Wearable Device
measure: Delirium
time frame: Postoperative Day 2 (after extubation)
description: Occurrence of delirium with few hours slept as measured by the Wireless Wearable Device
arm group label: Cardiac Surgery Cohort
description: Patients aged 18 years or older who are scheduled to undergo elective cardiac surgery with cardiopulmonary bypass.
intervention type: Device
intervention name: Wireless Wearable Device
description: Wireless Wearable Device will be placed on the wrist of the patient prior to extubation in the ICU to record patient activity in terms of steps and sleep quality.
arm group label: Cardiac Surgery Cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Sreekanth Cheruku, MD
role: Principal Investigator
affiliation: UT Southwestern Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Sreekanth Cheruku
investigator title: Assistant Professor
mesh term: Delirium
sharing ipd: No