<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/NCT03014336</url>
  </required_header>
  <id_info>
    <org_study_id>DMF-CLIN-16-01</org_study_id>
    <nct_id>NCT03014336</nct_id>
  </id_info>
  <brief_title>A New and Innovative Method for CO2 Removal in Anesthetic Circuits: Replacing Chemical Granulate</brief_title>
  <acronym>memsorb</acronym>
  <official_title>A New and Innovative Method for CO2 Removal in Anesthetic Circuits:</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>
      The drawbacks of chemical CO2 absorbers include the production of compounds harmful to&#xD;
      patients that also lead into increased cost and environmental impact, as well as the daily&#xD;
      disposal of compound special waste. Sustainable management of general anesthesia is a growing&#xD;
      concern. Continually diluting anesthetic circuits, and the disposal of chemical granulate are&#xD;
      serious environmental problems.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      DMF Medical has developed a next-generation CO2 filter in order to address the safety issues&#xD;
      with current chemical CO2 absorbers in anesthesia.&#xD;
&#xD;
      memsorb uses patented advanced medical membrane technology to filter CO2 from anesthetic&#xD;
      circuits rather than absorbing via a chemical reaction.&#xD;
&#xD;
      This game changing technology relies on a polymeric membrane core (similar to the ones used&#xD;
      in oxygenators for cardiac surgery) that selectively allows CO2 to leave the rebreathing&#xD;
      system, while maintaining the anesthetic vapor in the circuit.&#xD;
&#xD;
      memsorb is a cartridge similar in size and shape to current solutions that simply clicks in&#xD;
      place.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>End Tidal CO2</measure>
    <time_frame>Up to 12h</time_frame>
    <description>Concentration of carbon dioxide during expiratory cycle.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Fresh gas flow</measure>
    <time_frame>Up to 12h</time_frame>
    <description>Analysis of fresh gas flow into the machine.</description>
  </other_outcome>
  <other_outcome>
    <measure>Fractional concentration of inspired CO2</measure>
    <time_frame>Up to 12h</time_frame>
    <description>Analysis of concentration of CO2 during inspiratory cycle.</description>
  </other_outcome>
  <other_outcome>
    <measure>Fractional concentration of inspired O2</measure>
    <time_frame>Up to 12h</time_frame>
    <description>Analysis of concentration of O2 in inspired gas.</description>
  </other_outcome>
  <other_outcome>
    <measure>Arterial blood oxygen saturation</measure>
    <time_frame>Up to 12h</time_frame>
    <description>Saturation of oxygen in arterial blood where measured by pulse oximetry and/or blood gas analysis.</description>
  </other_outcome>
  <other_outcome>
    <measure>Arterial blood CO2 partial pressure</measure>
    <time_frame>Up to 12h</time_frame>
    <description>Saturation of carbon dioxide in arterial blood measured by a blood gas analyzer.</description>
  </other_outcome>
  <other_outcome>
    <measure>pH measurement</measure>
    <time_frame>Single collected measurement not more than 60 min after extubation</time_frame>
    <description>pH of the condensed water in the drain valve and the PAL filter.</description>
  </other_outcome>
  <other_outcome>
    <measure>Length of surgery</measure>
    <time_frame>Up to 12h</time_frame>
    <description>Duration of surgical procedure.</description>
  </other_outcome>
  <other_outcome>
    <measure>Ventilation frequency</measure>
    <time_frame>Up to 12h</time_frame>
    <description>Measurement of patient breathing rate.</description>
  </other_outcome>
  <other_outcome>
    <measure>Ventilation pressure</measure>
    <time_frame>Up to 12h</time_frame>
    <description>Measurement of patient inspiratory pressure.</description>
  </other_outcome>
  <other_outcome>
    <measure>Tidal volume</measure>
    <time_frame>Up to 12h</time_frame>
    <description>Measurement of total lung volume as represented by the volume of air displaced between normal inhalation and exhalation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient temperature</measure>
    <time_frame>Up to 12h</time_frame>
    <description>Body temperature of patient.</description>
  </other_outcome>
  <other_outcome>
    <measure>Relaxation status</measure>
    <time_frame>Up to 12h</time_frame>
    <description>Neuromuscular relaxation of patient.</description>
  </other_outcome>
  <other_outcome>
    <measure>Heart rate</measure>
    <time_frame>Up to 12h</time_frame>
    <description>Measurement and collection of patient heart rate.</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Up to 12h</time_frame>
    <description>Measurement and collection of patient mean, systolic and diastolic blood pressure.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient weight</measure>
    <time_frame>during preoperative assessment</time_frame>
    <description>Weight of patient as collected from anaesthesia patient record database.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient height</measure>
    <time_frame>during preoperative assessment</time_frame>
    <description>Height of patient as collected from anaesthesia patient record database.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient age</measure>
    <time_frame>during preoperative assessment</time_frame>
    <description>Age of patient as collected from anaesthesia patient record database.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient medications</measure>
    <time_frame>during preoperative assessment</time_frame>
    <description>Medications being taken by patient as collected from anaesthesia patient record database.</description>
  </other_outcome>
  <other_outcome>
    <measure>Lung disease</measure>
    <time_frame>during preoperative assessment</time_frame>
    <description>Incidence of lung disease as collected from anaesthesia patient record database.</description>
  </other_outcome>
  <other_outcome>
    <measure>Anaesthetic agent</measure>
    <time_frame>Up to 12h</time_frame>
    <description>Inhaled and exhaled fraction of anaesthetic agent as collected from the anaesthetic patient record database</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients receive standard care with a standard CO2 absorber and agree to include their data in the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>memsorb</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients agree to receive standard care but using memsorb, the new CO2 filter evaluated in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>memsorb</intervention_name>
    <description>memsorb is a CO2 filter replacing current chemical CO2 absorbers</description>
    <arm_group_label>memsorb</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists Physical Status Class I, II, III (low-medium&#xD;
             risk patient)&#xD;
&#xD;
          -  English-speaking patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Self-reported as pregnant&#xD;
&#xD;
          -  American Society of Anesthesiologists Physical Status Class IV (high risk patient)&#xD;
&#xD;
          -  Patients scheduled for emergency surgery&#xD;
&#xD;
          -  Documented respiratory disease, including COPD and severe asthma&#xD;
&#xD;
          -  Documented elevated pressure in the 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>
  <overall_official>
    <last_name>Orlando Hung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nova Scotia Health Authority</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Katy Scurman</last_name>
    <phone>(902) 221-0451</phone>
    <email>schurman@dmfmedical.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Vera Lloyd</last_name>
    <phone>(902) 225-3893</phone>
    <email>lloyd@dmfmedical.com</email>
  </overall_contact_backup>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Orlando Hung, MD</last_name>
      <phone>(902)473-7736</phone>
      <email>orlando.hung@dal.ca</email>
    </contact>
    <investigator>
      <last_name>Orlando Hung, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>October 12, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>November 18, 2022</last_update_submitted>
  <last_update_submitted_qc>November 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>co2 removal, anesthesia</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/NCT03014336
org study id: DMF-CLIN-16-01
nct id: NCT03014336
lead sponsor: 
has dmc: No
The drawbacks of chemical CO2 absorbers include the production of compounds harmful to
      patients that also lead into increased cost and environmental impact, as well as the daily
      disposal of compound special waste. Sustainable management of general anesthesia is a growing
      concern. Continually diluting anesthetic circuits, and the disposal of chemical granulate are
      serious environmental problems.
DMF Medical has developed a next-generation CO2 filter in order to address the safety issues
      with current chemical CO2 absorbers in anesthesia.

      memsorb uses patented advanced medical membrane technology to filter CO2 from anesthetic
      circuits rather than absorbing via a chemical reaction.

      This game changing technology relies on a polymeric membrane core (similar to the ones used
      in oxygenators for cardiac surgery) that selectively allows CO2 to leave the rebreathing
      system, while maintaining the anesthetic vapor in the circuit.

      memsorb is a cartridge similar in size and shape to current solutions that simply clicks in
      place.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: End Tidal CO2
time frame: Up to 12h
description: Concentration of carbon dioxide during expiratory cycle.
measure: Fresh gas flow
time frame: Up to 12h
description: Analysis of fresh gas flow into the machine.
measure: Fractional concentration of inspired CO2
time frame: Up to 12h
description: Analysis of concentration of CO2 during inspiratory cycle.
measure: Fractional concentration of inspired O2
time frame: Up to 12h
description: Analysis of concentration of O2 in inspired gas.
measure: Arterial blood oxygen saturation
time frame: Up to 12h
description: Saturation of oxygen in arterial blood where measured by pulse oximetry and/or blood gas analysis.
measure: Arterial blood CO2 partial pressure
time frame: Up to 12h
description: Saturation of carbon dioxide in arterial blood measured by a blood gas analyzer.
measure: pH measurement
time frame: Single collected measurement not more than 60 min after extubation
description: pH of the condensed water in the drain valve and the PAL filter.
measure: Length of surgery
time frame: Up to 12h
description: Duration of surgical procedure.
measure: Ventilation frequency
time frame: Up to 12h
description: Measurement of patient breathing rate.
measure: Ventilation pressure
time frame: Up to 12h
description: Measurement of patient inspiratory pressure.
measure: Tidal volume
time frame: Up to 12h
description: Measurement of total lung volume as represented by the volume of air displaced between normal inhalation and exhalation.
measure: Patient temperature
time frame: Up to 12h
description: Body temperature of patient.
measure: Relaxation status
time frame: Up to 12h
description: Neuromuscular relaxation of patient.
measure: Heart rate
time frame: Up to 12h
description: Measurement and collection of patient heart rate.
measure: Blood pressure
time frame: Up to 12h
description: Measurement and collection of patient mean, systolic and diastolic blood pressure.
measure: Patient weight
time frame: during preoperative assessment
description: Weight of patient as collected from anaesthesia patient record database.
measure: Patient height
time frame: during preoperative assessment
description: Height of patient as collected from anaesthesia patient record database.
measure: Patient age
time frame: during preoperative assessment
description: Age of patient as collected from anaesthesia patient record database.
measure: Patient medications
time frame: during preoperative assessment
description: Medications being taken by patient as collected from anaesthesia patient record database.
measure: Lung disease
time frame: during preoperative assessment
description: Incidence of lung disease as collected from anaesthesia patient record database.
measure: Anaesthetic agent
time frame: Up to 12h
description: Inhaled and exhaled fraction of anaesthetic agent as collected from the anaesthetic patient record database
arm group label: Control
arm group type: No Intervention
description: Patients receive standard care with a standard CO2 absorber and agree to include their data in the study.
arm group label: memsorb
arm group type: Experimental
description: Patients agree to receive standard care but using memsorb, the new CO2 filter evaluated in this study.
intervention type: Device
intervention name: memsorb
description: memsorb is a CO2 filter replacing current chemical CO2 absorbers
arm group label: memsorb
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Orlando Hung, MD
role: Principal Investigator
affiliation: Nova Scotia Health Authority
last name: Katy Scurman
phone: (902) 221-0451
email: schurman@dmfmedical.com
last name: Vera Lloyd
phone: (902) 225-3893
email: lloyd@dmfmedical.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
country: Canada
responsible party type: Sponsor
sharing ipd: No