<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/NCT03832205</url>
  </required_header>
  <id_info>
    <org_study_id>RHM CRI0371</org_study_id>
    <nct_id>NCT03832205</nct_id>
  </id_info>
  <brief_title>Validation of Respiratory Rate and Heart Rate Measurements by Capaciflectors Placed in Four Locations on the Chest</brief_title>
  <official_title>Validation of a Capaciflector Against a Pneumotachometer to Measure Respiratory Rate and a Capaciflector Against Electrocardiography to Measure Heart Rate at Different Anatomical Chest Locations During Cardiopulmonary Exercise Testing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Southampton NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southampton</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Southampton NHS Foundation Trust</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 a collaborative project between University Hospital Southampton NHS Trust and the&#xD;
      University of Southampton, the investigators have developed a wearable, mobile, non invasive,&#xD;
      low-cost, continuous respiratory rate monitor device called a capaciflector.&#xD;
&#xD;
      This study will be the first ever study undertaken to attempt to measure the respiratory rate&#xD;
      and heart rate on patients using a capaciflector. Investigators will evaluate whether the&#xD;
      correlation between the capaciflector's measurements of respiratory rate and heart rate when&#xD;
      compared with the gold standard pneumotachometer and electrocardiogram respectively is high&#xD;
      enough to promote its potential future use within a device for clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      RESEARCH QUESTION/AIM(S)&#xD;
&#xD;
      Will a capaciflector measure the respiratory rate as accurately as a pneumotachometer and the&#xD;
      heart rate as accurately as an electrocardiogram?&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        1. To test the reliability and accuracy of our capaciflector in measuring respiratory rate&#xD;
           and heart rate by comparing it with gold standard readings.&#xD;
&#xD;
        2. To assess whether different capaciflector locations around the body are all as accurate&#xD;
           as each other.&#xD;
&#xD;
      STUDY DESIGN and METHODS of DATA COLLECTION AND DATA ANALYSIS&#xD;
&#xD;
      Unblinded observational study - for each subject demographic data will be collected: age,&#xD;
      gender, height, weight, body mass index.&#xD;
&#xD;
      As well as the routine monitoring devices worn while undergoing a CPET test, the patients&#xD;
      will have 4 capaciflectors placed on them as well. These will be placed using hypoallergenic&#xD;
      medical grade tape.&#xD;
&#xD;
        -  Over the left precordium&#xD;
&#xD;
        -  Over the right precordium&#xD;
&#xD;
        -  Under the left axilla&#xD;
&#xD;
        -  Under the right axilla&#xD;
&#xD;
      Each practical component of the study setup will be delivered consistently by CI Dr Nick&#xD;
      Hayward, Student Doctor Alan Doughty, or cardiopulmonary exercise testing (CPET) technicians&#xD;
      once the study becomes established. The patient will then undergo a routine CPET and our&#xD;
      monitors will not affect what a patient is asked to do as part of the current CPET protocol.&#xD;
      If a patient is unable to finish the CPET then their data will still be included.&#xD;
&#xD;
      Raw CPET data will be exported via a feed from the CPET machine and also from the&#xD;
      capaciflectors. A laptop computer provided by the University will receive both data feeds.&#xD;
      Simultaneous recordings will be taken from each of the capaciflectors at time zero and then&#xD;
      at one minute intervals. These anonymous datasets will be stored on the laptop computer. Once&#xD;
      the CPET test is completed, the participant's involvement in the study will have ended.&#xD;
&#xD;
      Anonymised raw data analysis comparisons will be made by the Department of Engineering,&#xD;
      University of Southampton, in collaboration with the other investigators of this study. There&#xD;
      will be no patient identifiable information in any dataset, yet demographic data and raw CPET&#xD;
      acquired data will be held securely on the laptop in line with clinical governance&#xD;
      requirements of University Hospital Southampton. Statistical support by Dr Helen Moyses of&#xD;
      the Clinical Informatics Research Unit, Southampton, will be provided for data analysis at&#xD;
      the final stage.&#xD;
&#xD;
      STUDY SETTING&#xD;
&#xD;
      The study will be a single centre study at University Hospital Southampton. Participants will&#xD;
      have been recruited from the patients booked for a CPET test prior to them having major&#xD;
      surgery. The study will be conducted in the CPET department in the Day Surgery Unit. This is&#xD;
      where the CPET for patients routinely takes place.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2019</start_date>
  <completion_date type="Actual">October 28, 2019</completion_date>
  <primary_completion_date type="Actual">October 28, 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>Respiratory rate comparison</measure>
    <time_frame>Through study completion, an average of one year</time_frame>
    <description>Statistical comparisons between the two methods of measuring respiratory rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate comparison</measure>
    <time_frame>Through study completion, an average of one year</time_frame>
    <description>Statistical comparisons between the two methods of measuring heart rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Capaciflector location comparison</measure>
    <time_frame>Through study completion, an average of one year</time_frame>
    <description>Statistical comparisons between the four anatomical chest locations of our capaciflectors</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Exercise</condition>
  <condition>Respiratory Rate</condition>
  <condition>Heart Rate</condition>
  <arm_group>
    <arm_group_label>Capaciflector monitoring group</arm_group_label>
    <description>Patients undergoing their pre-planned, routine cardiopulmonary exercise test (CPET). Additional, non-invasive capaciflector monitoring only - no therapeutic intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Capaciflector monitoring</intervention_name>
    <description>Non-invasive capaciflector monitoring of respiratory rate and heart rate.</description>
    <arm_group_label>Capaciflector monitoring group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults undergoing routine clinical cardiopulmonary exercise testing (CPET).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 and over&#xD;
&#xD;
          -  Able to give informed consent in English&#xD;
&#xD;
          -  Able to at least start a CPET test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absolute contraindications to taking part in CPET:&#xD;
&#xD;
          -  Recent (within 5 days) Acute Myocardial Infarction&#xD;
&#xD;
          -  Unstable angina&#xD;
&#xD;
          -  Uncontrolled arrhythmia causing symptoms or haemodynamic compromise&#xD;
&#xD;
          -  Syncope&#xD;
&#xD;
          -  Active endocarditis, acute myocarditis or pericarditis&#xD;
&#xD;
          -  Symptomatic severe aortic stenosis&#xD;
&#xD;
          -  Uncontrolled heart failure&#xD;
&#xD;
          -  Suspected dissecting or leaking aortic aneurysm&#xD;
&#xD;
          -  Uncontrolled asthma&#xD;
&#xD;
          -  Arterial desaturation at rest on room air &lt; 85%&#xD;
&#xD;
          -  Known allergy to medical grade tape&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neil White, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Southampton</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Southampton NHS Foundation Trust</name>
      <address>
        <city>Southampton</city>
        <zip>SO50 9BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>White N. et al. (2017) A Planar Respiration Sensor Based on a Capaciflector Structure. IEEE Sensors Letters vol. 1 no. 4 pp. 1-4 Art no. 6000604. doi: 10.1109/LSENS.2017.2722481. http://ieeexplore.ieee.org/stamp/stamp.jsp?tp=&amp;arnumber=7967772&amp;isnumber=7949374</citation>
  </reference>
  <reference>
    <citation>Naranjo-Hernandez D, Talaminos-Barroso A, Reina-Tosina J, Roa LM, Barbarov-Rostan G, Cejudo-Ramos P, Marquez-Martin E, Ortega-Ruiz F. Smart Vest for Respiratory Rate Monitoring of COPD Patients Based on Non-Contact Capacitive Sensing. Sensors (Basel). 2018 Jul 3;18(7):2144. doi: 10.3390/s18072144.</citation>
    <PMID>29970861</PMID>
  </reference>
  <reference>
    <citation>Gerry S, Birks J, Bonnici T, Watkinson PJ, Kirtley S, Collins GS. Early warning scores for detecting deterioration in adult hospital patients: a systematic review protocol. BMJ Open. 2017 Dec 3;7(12):e019268. doi: 10.1136/bmjopen-2017-019268.</citation>
    <PMID>29203508</PMID>
  </reference>
  <reference>
    <citation>Effects of current on human beings and livestock - Part 1: General Aspects, section 4.5.4 (1993) Bureau of Indian Standards, New Delhi. http://questin.org/sites/default/files/standards/is.8437.1.1992_0.pdf</citation>
  </reference>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>October 23, 2018</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>December 11, 2019</last_update_submitted>
  <last_update_submitted_qc>December 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>No personal identifiable data will be shared. Physiological data may be shared with statisticians within the University or University Hospital. Data analysis may be partly conducted by Dr Peter Charlton, Kings College London, UK</ipd_description>
  </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/NCT03832205
org study id: RHM CRI0371
nct id: NCT03832205
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In a collaborative project between University Hospital Southampton NHS Trust and the
      University of Southampton, the investigators have developed a wearable, mobile, non invasive,
      low-cost, continuous respiratory rate monitor device called a capaciflector.

      This study will be the first ever study undertaken to attempt to measure the respiratory rate
      and heart rate on patients using a capaciflector. Investigators will evaluate whether the
      correlation between the capaciflector's measurements of respiratory rate and heart rate when
      compared with the gold standard pneumotachometer and electrocardiogram respectively is high
      enough to promote its potential future use within a device for clinical practice.
RESEARCH QUESTION/AIM(S)

      Will a capaciflector measure the respiratory rate as accurately as a pneumotachometer and the
      heart rate as accurately as an electrocardiogram?

      Objectives:

        1. To test the reliability and accuracy of our capaciflector in measuring respiratory rate
           and heart rate by comparing it with gold standard readings.

        2. To assess whether different capaciflector locations around the body are all as accurate
           as each other.

      STUDY DESIGN and METHODS of DATA COLLECTION AND DATA ANALYSIS

      Unblinded observational study - for each subject demographic data will be collected: age,
      gender, height, weight, body mass index.

      As well as the routine monitoring devices worn while undergoing a CPET test, the patients
      will have 4 capaciflectors placed on them as well. These will be placed using hypoallergenic
      medical grade tape.

        -  Over the left precordium

        -  Over the right precordium

        -  Under the left axilla

        -  Under the right axilla

      Each practical component of the study setup will be delivered consistently by CI Dr Nick
      Hayward, Student Doctor Alan Doughty, or cardiopulmonary exercise testing (CPET) technicians
      once the study becomes established. The patient will then undergo a routine CPET and our
      monitors will not affect what a patient is asked to do as part of the current CPET protocol.
      If a patient is unable to finish the CPET then their data will still be included.

      Raw CPET data will be exported via a feed from the CPET machine and also from the
      capaciflectors. A laptop computer provided by the University will receive both data feeds.
      Simultaneous recordings will be taken from each of the capaciflectors at time zero and then
      at one minute intervals. These anonymous datasets will be stored on the laptop computer. Once
      the CPET test is completed, the participant's involvement in the study will have ended.

      Anonymised raw data analysis comparisons will be made by the Department of Engineering,
      University of Southampton, in collaboration with the other investigators of this study. There
      will be no patient identifiable information in any dataset, yet demographic data and raw CPET
      acquired data will be held securely on the laptop in line with clinical governance
      requirements of University Hospital Southampton. Statistical support by Dr Helen Moyses of
      the Clinical Informatics Research Unit, Southampton, will be provided for data analysis at
      the final stage.

      STUDY SETTING

      The study will be a single centre study at University Hospital Southampton. Participants will
      have been recruited from the patients booked for a CPET test prior to them having major
      surgery. The study will be conducted in the CPET department in the Day Surgery Unit. This is
      where the CPET for patients routinely takes place.
observational model: Cohort
time perspective: Prospective
measure: Respiratory rate comparison
time frame: Through study completion, an average of one year
description: Statistical comparisons between the two methods of measuring respiratory rate
measure: Heart rate comparison
time frame: Through study completion, an average of one year
description: Statistical comparisons between the two methods of measuring heart rate
measure: Capaciflector location comparison
time frame: Through study completion, an average of one year
description: Statistical comparisons between the four anatomical chest locations of our capaciflectors
arm group label: Capaciflector monitoring group
description: Patients undergoing their pre-planned, routine cardiopulmonary exercise test (CPET). Additional, non-invasive capaciflector monitoring only - no therapeutic intervention.
intervention type: Device
intervention name: Capaciflector monitoring
description: Non-invasive capaciflector monitoring of respiratory rate and heart rate.
arm group label: Capaciflector monitoring group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Neil White, PhD
role: Study Director
affiliation: University of Southampton
facility: 
country: United Kingdom
citation: White N. et al. (2017) A Planar Respiration Sensor Based on a Capaciflector Structure. IEEE Sensors Letters vol. 1 no. 4 pp. 1-4 Art no. 6000604. doi: 10.1109/LSENS.2017.2722481. http://ieeexplore.ieee.org/stamp/stamp.jsp?tp=&arnumber=7967772&isnumber=7949374
citation: Naranjo-Hernandez D, Talaminos-Barroso A, Reina-Tosina J, Roa LM, Barbarov-Rostan G, Cejudo-Ramos P, Marquez-Martin E, Ortega-Ruiz F. Smart Vest for Respiratory Rate Monitoring of COPD Patients Based on Non-Contact Capacitive Sensing. Sensors (Basel). 2018 Jul 3;18(7):2144. doi: 10.3390/s18072144.
PMID: 29970861
citation: Gerry S, Birks J, Bonnici T, Watkinson PJ, Kirtley S, Collins GS. Early warning scores for detecting deterioration in adult hospital patients: a systematic review protocol. BMJ Open. 2017 Dec 3;7(12):e019268. doi: 10.1136/bmjopen-2017-019268.
PMID: 29203508
citation: Effects of current on human beings and livestock - Part 1: General Aspects, section 4.5.4 (1993) Bureau of Indian Standards, New Delhi. http://questin.org/sites/default/files/standards/is.8437.1.1992_0.pdf
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: No personal identifiable data will be shared. Physiological data may be shared with statisticians within the University or University Hospital. Data analysis may be partly conducted by Dr Peter Charlton, Kings College London, UK