<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/NCT01672073</url>
  </required_header>
  <id_info>
    <org_study_id>PROX005</org_study_id>
    <nct_id>NCT01672073</nct_id>
  </id_info>
  <brief_title>Analysis of the Arterial Pressure Wave Form Through the Proxima Device</brief_title>
  <official_title>An Open, Non-randomised, Study to Provide Data on the Arterial Pressure Wave Form Obtained Through the Proxima 3 in Patients Who Require the Insertion of an Arterial Line</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sphere Medical Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sphere Medical Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the trial is to confirm that the presence of the Proxima 3 disposable in the&#xD;
      arterial line doesn't significantly attenuate the arterial pressure wave form. The principal&#xD;
      aim of the trial will be:&#xD;
&#xD;
      • To obtain quantitative data allowing investigation of the pressure wave form obtained in a&#xD;
      standard arterial line compared to various arterial lines fitted with the Proxima 3.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to examine the transmission of the arterial pressure wave form&#xD;
      through Proxima 3 disposable attached to a configurable parts of the patient's arterial line.&#xD;
      The Proxima device has been tested by Intertek as part of the Proxima 2 project and found to&#xD;
      comply to BS EN 60601-1 2nd edition &quot;Medical electrical equipment - Part 1: General&#xD;
      requirements for basic safety and essential performance&quot;. Additional internal tests have also&#xD;
      been carried out for clause 51.103, frequency response, from BS EN 60601-2-34(2001).&#xD;
&#xD;
      This study part of the on-going development of the Proxima system which monitors metabolic&#xD;
      parameters in critically ill patients using a disposable sensor array. This study builds upon&#xD;
      the four clinical trials carried out in the past two years by Sphere Medical in partnership&#xD;
      with the NHS (REC references: 10/H1308/53, 10/H0308/113, 11/SW/0166, 12/SW/0175).&#xD;
&#xD;
      This study forms part of the development process for the Proxima family of devices.&#xD;
&#xD;
      The Proxima 3:&#xD;
&#xD;
        -  Is a disposable multi-parameter microanalyser&#xD;
&#xD;
        -  Is connected into the patient's arterial line.&#xD;
&#xD;
        -  Will measure all or some of blood gases, haematocrit and electrolytes and is connected&#xD;
           to a small bedside monitor, which displays the results.&#xD;
&#xD;
        -  Microanalyser can perform an unlimited number of analyses over a period of up to seventy&#xD;
           two hours.&#xD;
&#xD;
        -  Will be used as part of a closed system, reducing infection risk and preventing blood&#xD;
           loss.&#xD;
&#xD;
      Proxima 3 will enable clinicians to measure blood parameters without leaving the patient's&#xD;
      bedside. This will support the ability to respond rapidly to changing conditions in their&#xD;
      critically ill patients. The measurements made by the Proxima 3 system have the potential to&#xD;
      inform clinical decision support systems and to change, at a fundamental level, the ability&#xD;
      of clinicians to improve patient care.&#xD;
&#xD;
      In this study the Proxima 3 is a passive component. It will NOT be connected to the Proxima 3&#xD;
      monitor. NO blood will be taken and NO analysis of the blood analyte concentrations will&#xD;
      occur in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To confirm that siting Proxima 3 in the arterial line does not affect the pressure wave form</measure>
    <time_frame>10 minutes maximum</time_frame>
    <description>The data traces collected from the arterial pressure waveform monitor will undergo quantitative assessment to determine the effect on the pressure wave, if any, by introducing the Proxima 3 device in the system.</description>
  </primary_outcome>
  <enrollment type="Actual">10</enrollment>
  <condition>Local Pressure Effects</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated in the Intensive Care or High Dependency Units who require an arterial&#xD;
        line to be inserted as standard care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients over the age of 18&#xD;
&#xD;
          -  Patients will give full informed consent to participate in the study before inclusion.&#xD;
&#xD;
          -  All patients who have an arterial line inserted as standard care will be considered&#xD;
             for inclusion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of consent to participate&#xD;
&#xD;
          -  The patient is considered by the investigator to be unsuitable for the study&#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>Thomas Clutton-Brock, MB ChB FRCP</last_name>
    <role>Study Director</role>
    <affiliation>Queen Elizabeth Hopsital, Birmingham, UK</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>City and Borough of Birmingham</city>
        <state>Edgbaston</state>
        <zip>B15 2WB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.spheremedical.com</url>
    <description>Click here for more information about this study</description>
  </link>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>August 8, 2013</last_update_submitted>
  <last_update_submitted_qc>August 8, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 12, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pressure</keyword>
  <keyword>waveform</keyword>
  <keyword>arterial</keyword>
  <!-- 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/NCT01672073
org study id: PROX005
nct id: NCT01672073
lead sponsor: 
has dmc: No
The purpose of the trial is to confirm that the presence of the Proxima 3 disposable in the
      arterial line doesn't significantly attenuate the arterial pressure wave form. The principal
      aim of the trial will be:

      • To obtain quantitative data allowing investigation of the pressure wave form obtained in a
      standard arterial line compared to various arterial lines fitted with the Proxima 3.
The purpose of this study is to examine the transmission of the arterial pressure wave form
      through Proxima 3 disposable attached to a configurable parts of the patient's arterial line.
      The Proxima device has been tested by Intertek as part of the Proxima 2 project and found to
      comply to BS EN 60601-1 2nd edition "Medical electrical equipment - Part 1: General
      requirements for basic safety and essential performance". Additional internal tests have also
      been carried out for clause 51.103, frequency response, from BS EN 60601-2-34(2001).

      This study part of the on-going development of the Proxima system which monitors metabolic
      parameters in critically ill patients using a disposable sensor array. This study builds upon
      the four clinical trials carried out in the past two years by Sphere Medical in partnership
      with the NHS (REC references: 10/H1308/53, 10/H0308/113, 11/SW/0166, 12/SW/0175).

      This study forms part of the development process for the Proxima family of devices.

      The Proxima 3:

        -  Is a disposable multi-parameter microanalyser

        -  Is connected into the patient's arterial line.

        -  Will measure all or some of blood gases, haematocrit and electrolytes and is connected
           to a small bedside monitor, which displays the results.

        -  Microanalyser can perform an unlimited number of analyses over a period of up to seventy
           two hours.

        -  Will be used as part of a closed system, reducing infection risk and preventing blood
           loss.

      Proxima 3 will enable clinicians to measure blood parameters without leaving the patient's
      bedside. This will support the ability to respond rapidly to changing conditions in their
      critically ill patients. The measurements made by the Proxima 3 system have the potential to
      inform clinical decision support systems and to change, at a fundamental level, the ability
      of clinicians to improve patient care.

      In this study the Proxima 3 is a passive component. It will NOT be connected to the Proxima 3
      monitor. NO blood will be taken and NO analysis of the blood analyte concentrations will
      occur in this study.
observational model: Case-Only
time perspective: Prospective
measure: To confirm that siting Proxima 3 in the arterial line does not affect the pressure wave form
time frame: 10 minutes maximum
description: The data traces collected from the arterial pressure waveform monitor will undergo quantitative assessment to determine the effect on the pressure wave, if any, by introducing the Proxima 3 device in the system.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Clutton-Brock, MB ChB FRCP
role: Study Director
affiliation: Queen Elizabeth Hopsital, Birmingham, UK
facility: 
country: United Kingdom
url: http://www.spheremedical.com
description: Click here for more information about this study
responsible party type: Sponsor