<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/NCT03795831</url>
  </required_header>
  <id_info>
    <org_study_id>2017-14</org_study_id>
    <nct_id>NCT03795831</nct_id>
  </id_info>
  <brief_title>Validation Study in Patients of a Non-invasive Blood Pressure Monitor for Perioperative Use</brief_title>
  <official_title>Validation Study in Patients of a Non-invasive Blood Pressure Monitor for Perioperative Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Edwards Lifesciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</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>
      Collecting all available data (waveforms, beat to beat data, status data) generated by a non&#xD;
      invasive blood pressure monitor on each hand and compare this to the actual data obtained by&#xD;
      intra arterial (radial) monitoring.&#xD;
&#xD;
      This to see if the non invasive bloodpressure monitor can be validated for intraoperative&#xD;
      use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although a blood pressure monitoring device could be evaluated by the comparing systolic,&#xD;
      diastolic and mean arterial pressure to a reference pressure, it is the specific aim to&#xD;
      collect all available data (waveforms, beat to beat data, status data) generated by the blood&#xD;
      pressure monitor.&#xD;
&#xD;
      After data analysis and comparison to patient's actual intra-arterial waveform, the outcome&#xD;
      will be evaluated by Association for the Advancement of Medical Instrumentation (AAMI)&#xD;
      standards to see if the non invasive bloodpressure monitor can be validated for&#xD;
      intraoperative use.&#xD;
&#xD;
      The study is targeted at patients already monitored with a system that accurately measures&#xD;
      and stores the intra-arterial waveform, such as the FloTrac system in the EV1000 monitor.&#xD;
&#xD;
      This study is a substudy of a feasability protocol evaluating a new algorithm for the&#xD;
      Clearsight system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>validation systole, diastole, mean ABP and pulse pressure</measure>
    <time_frame>within 1 hour</time_frame>
    <description>accuracy and precision of invasive blood pressure curve vs non-invasive blood pressure curves(ipsilateral and contralateral)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>implementation of software alterations to improve systole, diastole, mean ABP accuracy and pulse pressure</measure>
    <time_frame>time during surgery</time_frame>
    <description>Comparison of the non-invasive blood pressure curve after software alterations to the reference and invasive arterial blood pressure curve</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Intraoperative Hypotension</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
    <description>Adult patients, undergoing surgery requiring general anesthesia, planned to be monitored with a system that accurately measures and stores the intra-arterial waveform.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ClearSight feasibility testing</intervention_name>
    <description>A cuff is placed on a finger of the patient. The ClearSight system uses a volume clamp technology allowing measuring of continuous blood pressure waveform. Note: There will only be observational recordings, no interventions</description>
    <arm_group_label>Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients in a perioperative setting already monitored with a system that accurately&#xD;
        measures and stores the intra-arterial waveform, such as the FloTrac system in the EV1000&#xD;
        monitor.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients whose arterial blood pressure is measured invasively with technology that&#xD;
             allows for the storage of the intra-arterial waveform with sufficient quality and&#xD;
             resolution (Flotrac).&#xD;
&#xD;
          -  Patients older than 18, for elective general surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patient conditions that are expected to potentially and significantly affect the transfer&#xD;
        of pressure between radial artery and the finger, e.g. due to recent finger fractures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>D.P. Veelo, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>inverstigator</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>D.P. Veelo, Dr</last_name>
    <phone>0031205662533</phone>
    <email>d.p.veelo@amc.uva.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Academic Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>D.P. Veelo, Dr.</last_name>
      <phone>0031205662533</phone>
      <email>d.p.veelo@amc.uva.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>D.P.Veelo</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03795831
org study id: 2017-14
nct id: NCT03795831
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Collecting all available data (waveforms, beat to beat data, status data) generated by a non
      invasive blood pressure monitor on each hand and compare this to the actual data obtained by
      intra arterial (radial) monitoring.

      This to see if the non invasive bloodpressure monitor can be validated for intraoperative
      use.
Although a blood pressure monitoring device could be evaluated by the comparing systolic,
      diastolic and mean arterial pressure to a reference pressure, it is the specific aim to
      collect all available data (waveforms, beat to beat data, status data) generated by the blood
      pressure monitor.

      After data analysis and comparison to patient's actual intra-arterial waveform, the outcome
      will be evaluated by Association for the Advancement of Medical Instrumentation (AAMI)
      standards to see if the non invasive bloodpressure monitor can be validated for
      intraoperative use.

      The study is targeted at patients already monitored with a system that accurately measures
      and stores the intra-arterial waveform, such as the FloTrac system in the EV1000 monitor.

      This study is a substudy of a feasability protocol evaluating a new algorithm for the
      Clearsight system.
observational model: Cohort
time perspective: Prospective
measure: validation systole, diastole, mean ABP and pulse pressure
time frame: within 1 hour
description: accuracy and precision of invasive blood pressure curve vs non-invasive blood pressure curves(ipsilateral and contralateral)
measure: implementation of software alterations to improve systole, diastole, mean ABP accuracy and pulse pressure
time frame: time during surgery
description: Comparison of the non-invasive blood pressure curve after software alterations to the reference and invasive arterial blood pressure curve
arm group label: Cohort
description: Adult patients, undergoing surgery requiring general anesthesia, planned to be monitored with a system that accurately measures and stores the intra-arterial waveform.
intervention type: Device
intervention name: ClearSight feasibility testing
description: A cuff is placed on a finger of the patient. The ClearSight system uses a volume clamp technology allowing measuring of continuous blood pressure waveform. Note: There will only be observational recordings, no interventions
arm group label: Cohort
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: D.P. Veelo, Dr
role: Principal Investigator
affiliation: inverstigator
last name: D.P. Veelo, Dr
phone: 0031205662533
email: d.p.veelo@amc.uva.nl
facility: 
status: Recruiting
contact: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: D.P.Veelo
investigator title: Principal investigator
mesh term: Hypotension
sharing ipd: Undecided