<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/NCT03306537</url>
  </required_header>
  <id_info>
    <org_study_id>PMD-CS-011</org_study_id>
    <nct_id>NCT03306537</nct_id>
  </id_info>
  <brief_title>Sensor Validation Study - Quality Assurance</brief_title>
  <official_title>A Quality Assurance Study of Respiratory Rate Measurements on Obese Patients With a Novel Monitoring Technology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PMD Solutions</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PMD Solutions</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>
      The respiratory rate is an important parameter in clinical medicine. It is defined as the&#xD;
      number of breaths per minute. Currently this is measured at the bedside in clinical practice&#xD;
      by counting the breaths, however the gold standard for measuring this vital sign is the&#xD;
      capnograph. For the patient, this involves wearing a tube in their nose and around their ears&#xD;
      while trying to minimise their movement and talking so that the measurements can be taken.&#xD;
&#xD;
      A new respiratory rate monitor, RespiraSense, is non-invasive and measures the respiratory&#xD;
      rate by measuring the displacement between the ribs and abdomen. This research study is&#xD;
      intended to validate that this technology is effective and accurate on people with a bigger&#xD;
      body mass.&#xD;
&#xD;
      Subjects with a BMI &gt; 35 will be invited to participate should they meet all of the&#xD;
      eligibility criteria. If patients agree to participate, following informed consent, subjects&#xD;
      will be monitored for one hour with both the capnograph and RespiraSense measuring at the&#xD;
      same time so their results can be compared&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 28, 2017</start_date>
  <completion_date type="Actual">September 7, 2018</completion_date>
  <primary_completion_date type="Actual">August 7, 2018</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>Comparison of PMD RespiraSense against capnography in obese patients.</measure>
    <time_frame>1 hour</time_frame>
    <description>Analysed using a Bland Altman (BA) analysis to measure limits of agreement between both methods. The BA analysis will correct for repeated measures within each subject if required. In addition, a Deming Regression will be performed on the collected data.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of PMD RespiraSense in obese patients with BMI below 50 and those with BMI of 50 or above.</measure>
    <time_frame>1 hour</time_frame>
    <description>Analysed using a Bland Altman (BA) analysis to measure limits of agreement between both methods. The BA analysis will correct for repeated measures within each subject if required. In addition, a Deming Regression will be performed on the collected data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of any accuracy spread patterns as BMI increases.</measure>
    <time_frame>1 hour</time_frame>
    <description>Analysed using a Bland Altman (BA) analysis to measure limits of agreement between both methods. The BA analysis will correct for repeated measures within each subject if required. In addition, a Deming Regression will be performed on the collected data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Collection of feedback on device comfort when worn by patients with high BMI.</measure>
    <time_frame>1 hour</time_frame>
    <description>Will not be analysed formally.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exploratory: To measure RespiraSense device alarm generation and assess the rationale behind these to determine if false alarms and therefore alarm fatigue is occurring</measure>
    <time_frame>1 hour</time_frame>
    <description>Will not be analysed formally.</description>
  </other_outcome>
  <enrollment type="Actual">34</enrollment>
  <condition>Respiratory Rate</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RespiraSense Respiratory Rate Monitor</intervention_name>
    <description>RespiraSense device will be attached at the same time as the capnograph (gold standard) and both will measure simultaneously for one hour</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Obese patients with a BMI ≥35&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 Years&#xD;
&#xD;
          -  Have a BMI ≥35&#xD;
&#xD;
               -  For the sub-group analysis at least 5 subjects with a BMI 35-49 and at least 5&#xD;
                  BMI &gt; 50 will be needed&#xD;
&#xD;
          -  Are willing to voluntarily sign a statement of informed consent to participate in this&#xD;
             investigation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergic to medical grade skin adhesive&#xD;
&#xD;
          -  Continuous oral long term steroid use. To be free from oral steroid use this is&#xD;
             defined as not using oral steroids in the 4 weeks previous to enrolment&#xD;
&#xD;
          -  Patients under the influence of substance abuse (drug or alcohol) that may interfere&#xD;
             with their ability to cooperate and comply with the investigation procedures&#xD;
&#xD;
          -  Any disorder, including cognitive dysfunction, which would affect the ability to&#xD;
             accurately complete questionnaires and freely give full informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lorraine Albon</last_name>
    <role>Principal Investigator</role>
    <affiliation>Portsmouth Hospitals NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Alexandra Hospital</name>
      <address>
        <city>Portsmouth</city>
        <zip>PO6 3LY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>October 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>March 19, 2019</last_update_submitted>
  <last_update_submitted_qc>March 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03306537
org study id: PMD-CS-011
nct id: NCT03306537
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The respiratory rate is an important parameter in clinical medicine. It is defined as the
      number of breaths per minute. Currently this is measured at the bedside in clinical practice
      by counting the breaths, however the gold standard for measuring this vital sign is the
      capnograph. For the patient, this involves wearing a tube in their nose and around their ears
      while trying to minimise their movement and talking so that the measurements can be taken.

      A new respiratory rate monitor, RespiraSense, is non-invasive and measures the respiratory
      rate by measuring the displacement between the ribs and abdomen. This research study is
      intended to validate that this technology is effective and accurate on people with a bigger
      body mass.

      Subjects with a BMI > 35 will be invited to participate should they meet all of the
      eligibility criteria. If patients agree to participate, following informed consent, subjects
      will be monitored for one hour with both the capnograph and RespiraSense measuring at the
      same time so their results can be compared
observational model: Cohort
time perspective: Prospective
measure: Comparison of PMD RespiraSense against capnography in obese patients.
time frame: 1 hour
description: Analysed using a Bland Altman (BA) analysis to measure limits of agreement between both methods. The BA analysis will correct for repeated measures within each subject if required. In addition, a Deming Regression will be performed on the collected data.
measure: Comparison of PMD RespiraSense in obese patients with BMI below 50 and those with BMI of 50 or above.
time frame: 1 hour
description: Analysed using a Bland Altman (BA) analysis to measure limits of agreement between both methods. The BA analysis will correct for repeated measures within each subject if required. In addition, a Deming Regression will be performed on the collected data.
measure: Identification of any accuracy spread patterns as BMI increases.
time frame: 1 hour
description: Analysed using a Bland Altman (BA) analysis to measure limits of agreement between both methods. The BA analysis will correct for repeated measures within each subject if required. In addition, a Deming Regression will be performed on the collected data.
measure: Collection of feedback on device comfort when worn by patients with high BMI.
time frame: 1 hour
description: Will not be analysed formally.
measure: Exploratory: To measure RespiraSense device alarm generation and assess the rationale behind these to determine if false alarms and therefore alarm fatigue is occurring
time frame: 1 hour
description: Will not be analysed formally.
intervention type: Device
intervention name: RespiraSense Respiratory Rate Monitor
description: RespiraSense device will be attached at the same time as the capnograph (gold standard) and both will measure simultaneously for one hour
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Lorraine Albon
role: Principal Investigator
affiliation: Portsmouth Hospitals NHS Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No