<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/NCT04506775</url>
  </required_header>
  <id_info>
    <org_study_id>H00019883</org_study_id>
    <nct_id>NCT04506775</nct_id>
  </id_info>
  <brief_title>Comparison of Non-invasive and Invasive Blood Pressure Monitors</brief_title>
  <official_title>Comparison of a Standalone, Continuous, Non-invasive Blood Pressure Monitor (cNIBP) to Radial Arterial Catheterization in Patients Undergoing Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Massachusetts, Worcester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Massachusetts, Worcester</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare a noninvasive and continuous radial artery blood pressure measurements utilizing&#xD;
      ViTrack (developed by Dynocardia) to the standard of care radial artery catheterization, in&#xD;
      patients undergoing surgery or those who are being cared for in the intensive care unit&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ViTrack is strapped over the radial artery at the wrist.The ViTrack blood pressure cuff&#xD;
      will be utilized to obtain continuous blood pressure (BP) readings throughout the surgical&#xD;
      procedure or intensive care unit. This will allow us to compare BP readings between the&#xD;
      non-invasive ViTrack device and the standard of care invasive intra-arterial catheters&#xD;
      readings. Data collection from both the ViTrack and arterial catheter occur in the opposite&#xD;
      wrists.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single group design, patients are their own control.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>None, patients are their own control.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of Diastolic Blood Pressure</measure>
    <time_frame>Up to 24 Hours</time_frame>
    <description>255 time points compared across continuous blood pressure (mmHg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of Systolic Blood Pressure</measure>
    <time_frame>Up to 24 Hours</time_frame>
    <description>255 time points compared across continuous blood pressure (mmHg)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Skin Irritation</measure>
    <time_frame>Up to 72 hours</time_frame>
    <description>Examining for local skin irritation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Blood Pressure</condition>
  <condition>Surgery</condition>
  <condition>Intensive Care Unit</condition>
  <arm_group>
    <arm_group_label>Wrist one</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Wrist one will have both the ViTrack wrist cuff on one wrist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wrist Two</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Wrist two and the radial artery catheter in the opposite wrist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ViTrack</intervention_name>
    <description>ViTrack is a continuous non-invasive wearable blood pressure cuff.</description>
    <arm_group_label>Wrist one</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radial artery catheterization</intervention_name>
    <description>Radial artery catheterization is the standard of care for measuring blood pressure continuously throughout surgery.</description>
    <arm_group_label>Wrist Two</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between the ages of 18 - 90 years age who are undergoing any surgery or in&#xD;
             the intensive care unit and require intra-arterial catheterization for continuous BP&#xD;
             measurement.&#xD;
&#xD;
          -  Patients having elective surgeries.&#xD;
&#xD;
          -  Patients having emergent surgeries, but only if research staff can have appropriate&#xD;
             time to review study with patient and obtain signature on fact sheet prior to&#xD;
             administration of medications that could affect coherency.&#xD;
&#xD;
          -  Patients who are able to review, verbalize understanding, and sign fact sheet. If&#xD;
             patient has a health care proxy (HCP) or legal guardian, study will be reviewed, and&#xD;
             signature of HCP or legal guardian will be obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to obtain consent from the patient, HCP or legal guardian&#xD;
&#xD;
          -  Greater than 10% difference in BP measurements between both arms prior to surgery&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Inability to insert a radial artery catheter&#xD;
&#xD;
          -  Any other condition that would increase the risk of participation in the study in the&#xD;
             opinion of the site Investigator&#xD;
&#xD;
          -  Upper extremity arteriovenous haemodialysis shunt&#xD;
&#xD;
          -  Upper extremity amputation&#xD;
&#xD;
          -  Surgical position/draping precludes access to the wrist.&#xD;
&#xD;
          -  Wrist distortion or pain from arthritis&#xD;
&#xD;
          -  Prior trauma or surgery at the radial artery monitoring site&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James A Scott, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Massachusetts, Worcester</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Arlene Williams</last_name>
    <phone>5082316117</phone>
    <email>arlene.williams@umassmed.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Massachusetts Medical School</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arlene Williams</last_name>
      <phone>508-231-6117</phone>
      <email>arlene.williams@umassmed.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Heard SO, Lisbon A, Toth I, Ramasubramanian R. An evaluation of a new continuous blood pressure monitoring system in critically ill patients. J Clin Anesth. 2000 Nov;12(7):509-18. doi: 10.1016/s0952-8180(00)00201-4.</citation>
    <PMID>11137411</PMID>
  </results_reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Massachusetts, Worcester</investigator_affiliation>
    <investigator_full_name>James Aaron Scott</investigator_full_name>
    <investigator_title>Assistant Professor of Anesthesiology &amp; Perioperative Medicine</investigator_title>
  </responsible_party>
  <keyword>Blood Pressure</keyword>
  <keyword>BP</keyword>
  <keyword>Surgery</keyword>
  <keyword>Radial Artery Catheter</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Results and de-identified data will be securely shared with the sponsor. Sponsor may only see subject initials and study ID #. All other data will de-identified for review purposes and transferred via a secure method following the universities data sharing agreement with the sponsor.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data will become available following data analysis within 6 months of study completion and will remain available for up to 3 years.</ipd_time_frame>
    <ipd_access_criteria>Data will be accessed via secure methods outlined in a data sharing agreement.</ipd_access_criteria>
  </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/NCT04506775
org study id: H00019883
nct id: NCT04506775
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
To compare a noninvasive and continuous radial artery blood pressure measurements utilizing
      ViTrack (developed by Dynocardia) to the standard of care radial artery catheterization, in
      patients undergoing surgery or those who are being cared for in the intensive care unit
The ViTrack is strapped over the radial artery at the wrist.The ViTrack blood pressure cuff
      will be utilized to obtain continuous blood pressure (BP) readings throughout the surgical
      procedure or intensive care unit. This will allow us to compare BP readings between the
      non-invasive ViTrack device and the standard of care invasive intra-arterial catheters
      readings. Data collection from both the ViTrack and arterial catheter occur in the opposite
      wrists.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Single group design, patients are their own control.
primary purpose: Prevention
masking: None (Open Label)
masking description: None, patients are their own control.
measure: Comparison of Diastolic Blood Pressure
time frame: Up to 24 Hours
description: 255 time points compared across continuous blood pressure (mmHg)
measure: Comparison of Systolic Blood Pressure
time frame: Up to 24 Hours
description: 255 time points compared across continuous blood pressure (mmHg)
measure: Skin Irritation
time frame: Up to 72 hours
description: Examining for local skin irritation
arm group label: Wrist one
arm group type: Experimental
description: Wrist one will have both the ViTrack wrist cuff on one wrist
arm group label: Wrist Two
arm group type: Active Comparator
description: Wrist two and the radial artery catheter in the opposite wrist.
intervention type: Device
intervention name: ViTrack
description: ViTrack is a continuous non-invasive wearable blood pressure cuff.
arm group label: Wrist one
intervention type: Procedure
intervention name: Radial artery catheterization
description: Radial artery catheterization is the standard of care for measuring blood pressure continuously throughout surgery.
arm group label: Wrist Two
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: James A Scott, DO
role: Principal Investigator
affiliation: University of Massachusetts, Worcester
last name: Arlene Williams
phone: 5082316117
email: arlene.williams@umassmed.edu
facility: 
status: Recruiting
contact: 
country: United States
citation: Heard SO, Lisbon A, Toth I, Ramasubramanian R. An evaluation of a new continuous blood pressure monitoring system in critically ill patients. J Clin Anesth. 2000 Nov;12(7):509-18. doi: 10.1016/s0952-8180(00)00201-4.
PMID: 11137411
responsible party type: Principal Investigator
investigator affiliation: University of Massachusetts, Worcester
investigator full name: James Aaron Scott
investigator title: Assistant Professor of Anesthesiology & Perioperative Medicine
sharing ipd: Yes
ipd description: Results and de-identified data will be securely shared with the sponsor. Sponsor may only see subject initials and study ID #. All other data will de-identified for review purposes and transferred via a secure method following the universities data sharing agreement with the sponsor.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data will become available following data analysis within 6 months of study completion and will remain available for up to 3 years.
ipd access criteria: Data will be accessed via secure methods outlined in a data sharing agreement.