<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/NCT04480385</url>
  </required_header>
  <id_info>
    <org_study_id>19-009</org_study_id>
    <nct_id>NCT04480385</nct_id>
  </id_info>
  <brief_title>REmote Data Acquisition After SURgery</brief_title>
  <acronym>REDASUR</acronym>
  <official_title>Study of the Technological and Operational Feasibility of a Remote Automated Monitoring System for the Post-operative Care of Surgical Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IHU Strasbourg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rhythm Diagnostic Systems</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>IHU Strasbourg</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>
      In this clinical study, the investigators will compare vital parameters measurements obtained&#xD;
      using continuous data from reference monitors and continuous wireless MultiSense® monitoring&#xD;
      patch in 60 patients immediately after in-ward surgery and over 7 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The MultiSense® strip is a unique, band aid-sized, clinical signal quality, connected strip&#xD;
      for real-time monitoring of cardio-respiratory parameters. The MultiSense® strip measures in&#xD;
      real-time, remotely and continuously 11 clinical key-indicators by being attached to the&#xD;
      patient thorax: Electrocardiogram (ECG) trace, heart rate, oxygen saturation, respiratory&#xD;
      rate and relative respiration depth, pulse transit time, plethysmographic trace, perfusion&#xD;
      index, skin temperature, physical activity and body position. Designed to be worn&#xD;
      continuously for at least seven days, the patient can keep the patch during his sleep or in&#xD;
      the shower.&#xD;
&#xD;
      The aim of this study is to determine the quality of measurements of clinical signs provided&#xD;
      by MultiSense® strip in comparison to measurements made with conventional medical devices in&#xD;
      the hospital setting, in terms of accuracy, connectivity, generation of artefactual data and&#xD;
      stability of data transmission. The study population includes 60 patients undergoing visceral&#xD;
      or digestive surgery. Once in the post-operative monitoring room, the MultiSense® strip will&#xD;
      be attached on patient's thorax. The monitoring will last 7 days through post-operative&#xD;
      monitoring room (continuous comparison with reference monitor), general ward (comparison with&#xD;
      spot-check monitoring) and patient's home.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2020</start_date>
  <completion_date type="Actual">May 20, 2022</completion_date>
  <primary_completion_date type="Actual">May 20, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of accuracy.</measure>
    <time_frame>from patch placement to hospital discharge, assessed up to 1 week</time_frame>
    <description>Accuracy is defined as an average measurement variation less than 3.5 percent or 5 percent of the mean value, depending on the variable with respect to the reference standard.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of connectivity.</measure>
    <time_frame>from patch placement to hospital discharge, assessed up to 1 week</time_frame>
    <description>Connectivity is defined as a time-wise ratio of missing versus total signal less than 20 percent.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of generation of artefactual data.</measure>
    <time_frame>from patch placement to hospital discharge, assessed up to 1 week</time_frame>
    <description>The generation of artefact data is defined as a percentage of outlier data less than 10 percent.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of stability of data transmission.</measure>
    <time_frame>from patch placement to hospital discharge, assessed up to 1 week</time_frame>
    <description>Data transmission stability is defined as a data transmission rate equal to or greater than 80 percent.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Usability of a data acquisition patch by health care providers (HCPs) in different hospital settings assessed via questionnaires.</measure>
    <time_frame>At hospital discharge, up to 7 days after the patch placement</time_frame>
    <description>Descriptive determination of user-friendliness, comprehensibility and ease of placement, connection and removal of the data acquisition patch by healthcare providers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>User experience of surgical patients with the continuous use of a data acquisition patch during remote postoperative monitoring assessed via patient's final questionnaires.</measure>
    <time_frame>From patch placement to its removal (7 days)</time_frame>
    <description>Descriptive determination of user experience and practicalities associated with wearing the data acquisition patch (e.g. portability, duration of skin adhesion, anticipated detachment, interference with activities and stigma perception).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess patients' tolerability to prolonged use of an adhesive patch during remote postoperative monitoring.</measure>
    <time_frame>From patch placement to its removal (7 days)</time_frame>
    <description>Number of unexpected local and distant events attributable to the use of the adhesive data acquisition patch.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Visceral and Digestive Surgery</condition>
  <arm_group>
    <arm_group_label>Remote Automated Monitoring System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MultiSense® strip will be attached on patient's thorax. The monitoring will last 7 days through post-operative monitoring room (continuous comparison with reference monitor), general ward (comparison with spot-check monitoring) and patient's home</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Remote Automated Monitoring System</intervention_name>
    <description>The patient will be monitored with conventional monitoring devices as well as the MultiSense patch</description>
    <arm_group_label>Remote Automated Monitoring System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Man or woman over 18 years old&#xD;
&#xD;
          -  Patient programmed for an elective in-ward surgery&#xD;
&#xD;
          -  Patient located in Strasbourg area&#xD;
&#xD;
          -  Patient with Wi-Fi and/or Cellular connectivity at home&#xD;
&#xD;
          -  Patient able to receive and understand information related to the study and give&#xD;
             written informed consent.&#xD;
&#xD;
          -  Patient affiliated to the French social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with a skin disease that would not allow the use of an adhesive&#xD;
&#xD;
          -  Patient with an implantable device such as a pacemaker&#xD;
&#xD;
          -  Pregnant or lactating patient&#xD;
&#xD;
          -  Patient in exclusion period (determined by a previous or a current study)&#xD;
&#xD;
          -  Patient under guardianship or trusteeship&#xD;
&#xD;
          -  Patient under the protection of justice&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michel VIX, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de Chirurgie Digestive et Endocrinienne, NHC</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>February 23, 2023</last_update_submitted>
  <last_update_submitted_qc>February 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vital signs</keyword>
  <keyword>Connected device</keyword>
  <keyword>real-time monitoring</keyword>
  <keyword>post-surgery monitoring</keyword>
  <keyword>cardio-respiratory monitoring</keyword>
  <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/NCT04480385
org study id: 19-009
nct id: NCT04480385
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this clinical study, the investigators will compare vital parameters measurements obtained
      using continuous data from reference monitors and continuous wireless MultiSense® monitoring
      patch in 60 patients immediately after in-ward surgery and over 7 days.
The MultiSense® strip is a unique, band aid-sized, clinical signal quality, connected strip
      for real-time monitoring of cardio-respiratory parameters. The MultiSense® strip measures in
      real-time, remotely and continuously 11 clinical key-indicators by being attached to the
      patient thorax: Electrocardiogram (ECG) trace, heart rate, oxygen saturation, respiratory
      rate and relative respiration depth, pulse transit time, plethysmographic trace, perfusion
      index, skin temperature, physical activity and body position. Designed to be worn
      continuously for at least seven days, the patient can keep the patch during his sleep or in
      the shower.

      The aim of this study is to determine the quality of measurements of clinical signs provided
      by MultiSense® strip in comparison to measurements made with conventional medical devices in
      the hospital setting, in terms of accuracy, connectivity, generation of artefactual data and
      stability of data transmission. The study population includes 60 patients undergoing visceral
      or digestive surgery. Once in the post-operative monitoring room, the MultiSense® strip will
      be attached on patient's thorax. The monitoring will last 7 days through post-operative
      monitoring room (continuous comparison with reference monitor), general ward (comparison with
      spot-check monitoring) and patient's home.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of accuracy.
time frame: from patch placement to hospital discharge, assessed up to 1 week
description: Accuracy is defined as an average measurement variation less than 3.5 percent or 5 percent of the mean value, depending on the variable with respect to the reference standard.
measure: Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of connectivity.
time frame: from patch placement to hospital discharge, assessed up to 1 week
description: Connectivity is defined as a time-wise ratio of missing versus total signal less than 20 percent.
measure: Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of generation of artefactual data.
time frame: from patch placement to hospital discharge, assessed up to 1 week
description: The generation of artefact data is defined as a percentage of outlier data less than 10 percent.
measure: Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of stability of data transmission.
time frame: from patch placement to hospital discharge, assessed up to 1 week
description: Data transmission stability is defined as a data transmission rate equal to or greater than 80 percent.
measure: Usability of a data acquisition patch by health care providers (HCPs) in different hospital settings assessed via questionnaires.
time frame: At hospital discharge, up to 7 days after the patch placement
description: Descriptive determination of user-friendliness, comprehensibility and ease of placement, connection and removal of the data acquisition patch by healthcare providers.
measure: User experience of surgical patients with the continuous use of a data acquisition patch during remote postoperative monitoring assessed via patient's final questionnaires.
time frame: From patch placement to its removal (7 days)
description: Descriptive determination of user experience and practicalities associated with wearing the data acquisition patch (e.g. portability, duration of skin adhesion, anticipated detachment, interference with activities and stigma perception).
measure: Assess patients' tolerability to prolonged use of an adhesive patch during remote postoperative monitoring.
time frame: From patch placement to its removal (7 days)
description: Number of unexpected local and distant events attributable to the use of the adhesive data acquisition patch.
arm group label: Remote Automated Monitoring System
arm group type: Experimental
description: MultiSense® strip will be attached on patient's thorax. The monitoring will last 7 days through post-operative monitoring room (continuous comparison with reference monitor), general ward (comparison with spot-check monitoring) and patient's home
intervention type: Other
intervention name: Remote Automated Monitoring System
description: The patient will be monitored with conventional monitoring devices as well as the MultiSense patch
arm group label: Remote Automated Monitoring System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michel VIX, MD, PhD
role: Principal Investigator
affiliation: Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No