<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/NCT02195245</url>
  </required_header>
  <id_info>
    <org_study_id>DMF-CLIN-14-01</org_study_id>
    <nct_id>NCT02195245</nct_id>
  </id_info>
  <brief_title>A New and Innovative Method for CO2 Removal in Anesthetic Circuits: Replacing Chemical Granulate</brief_title>
  <official_title>A New and Innovative Method for CO2 Removal in Anesthetic Circuits: Replacing Chemical Granulate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DMF Medical Incorporated</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DMF Medical Incorporated</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      CO2 removal is a mandatory part of modern anesthesia systems. Current chemical absorbers pose&#xD;
      problems as the chemical granulate reacts not only with the CO2 but also the anesthetic&#xD;
      drugs, producing organ toxic substances. The proposed CO2 absorber provides a solution to the&#xD;
      problem of organ-toxin production in anesthetic circuits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CO2 removal is a mandatory part of modern anesthesia systems. Current chemical absorbers pose&#xD;
      problems as the chemical granulate reacts not only with the CO2 but also the anesthetic&#xD;
      drugs, producing organ toxic substances. The proposed CO2 absorber provides a solution to the&#xD;
      problem of organ-toxin production in anesthetic circuits.&#xD;
&#xD;
      This new absorber can be easily integrated into any anesthesia circuit, and can effectively&#xD;
      remove CO2 without reacting with anesthetic drugs, thus eliminating organ-toxic by-products.&#xD;
&#xD;
      It uses advanced membrane technology to separate gas flows within the circuit, separating the&#xD;
      expensive anesthetic vapors from the CO2 (the main by-product of metabolism). Anesthetic&#xD;
      vapors thus remain in the closed loop circuit, while CO2 is separated and exhausted to the&#xD;
      atmosphere, rather than being absorbed through a chemical reaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>End tidal CO2 level</measure>
    <time_frame>Continuous (5min intervals) over duration of anesthesia. No data collection prior or post anesthesia.</time_frame>
    <description>After completion of the surgery, the digital respiration records are exported from the hospital database.&#xD;
End tidal CO2 is assessed as either in range [4.1-5.6]% or out of range &lt;4.1% or &gt;5.6%.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>End Tidal CO2</condition>
  <condition>CO2 Removal</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control - Observational (non interventional) data is collected from current state of the art absorber devices.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>memsorb</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>New CO2 filter - data is collected using the new CO2 absorber.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>memsorb</intervention_name>
    <arm_group_label>memsorb</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiology Physical Status Class I, II, III (low-medium risk&#xD;
             patient)&#xD;
&#xD;
          -  English-speaking patients&#xD;
&#xD;
          -  Scheduled for elective surgery&#xD;
&#xD;
          -  Length of anesthesia ≥ 60 minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  American Society of Anesthesiology Physical Status Class IV (high risk patient)&#xD;
&#xD;
          -  Patients schedule for emergency surgery&#xD;
&#xD;
          -  Known respiratory disease, including COPD and severe asthma&#xD;
&#xD;
          -  Have elevated pressure in your brain (intra cranial pressure, ICP)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Queen Elizabeth II HSC, Halifax Infirmary Site</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 3A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>October 12, 2016</last_update_submitted>
  <last_update_submitted_qc>October 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CO2 filter</keyword>
  <keyword>anesthesia</keyword>
  <keyword>device</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/NCT02195245
org study id: DMF-CLIN-14-01
nct id: NCT02195245
lead sponsor: 
has dmc: No
CO2 removal is a mandatory part of modern anesthesia systems. Current chemical absorbers pose
      problems as the chemical granulate reacts not only with the CO2 but also the anesthetic
      drugs, producing organ toxic substances. The proposed CO2 absorber provides a solution to the
      problem of organ-toxin production in anesthetic circuits.
CO2 removal is a mandatory part of modern anesthesia systems. Current chemical absorbers pose
      problems as the chemical granulate reacts not only with the CO2 but also the anesthetic
      drugs, producing organ toxic substances. The proposed CO2 absorber provides a solution to the
      problem of organ-toxin production in anesthetic circuits.

      This new absorber can be easily integrated into any anesthesia circuit, and can effectively
      remove CO2 without reacting with anesthetic drugs, thus eliminating organ-toxic by-products.

      It uses advanced membrane technology to separate gas flows within the circuit, separating the
      expensive anesthetic vapors from the CO2 (the main by-product of metabolism). Anesthetic
      vapors thus remain in the closed loop circuit, while CO2 is separated and exhausted to the
      atmosphere, rather than being absorbed through a chemical reaction.
allocation: Non-Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: End tidal CO2 level
time frame: Continuous (5min intervals) over duration of anesthesia. No data collection prior or post anesthesia.
description: After completion of the surgery, the digital respiration records are exported from the hospital database.
End tidal CO2 is assessed as either in range [4.1-5.6]% or out of range <4.1% or >5.6%.
arm group label: Control
arm group type: No Intervention
description: Control - Observational (non interventional) data is collected from current state of the art absorber devices.
arm group label: memsorb
arm group type: Experimental
description: New CO2 filter - data is collected using the new CO2 absorber.
intervention type: Device
intervention name: memsorb
arm group label: memsorb
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor