Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A New and Innovative Method for CO2 Removal in Anesthetic Circuits: Replacing Chemical Granulate (memsorb)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03014336
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
DMF Medical Incorporated

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anesthesia Device: memsorb Not Applicable

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A New and Innovative Method for CO2 Removal in Anesthetic Circuits:
Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Patients receive standard care with a standard CO2 absorber and agree to include their data in the study.
Experimental: memsorb
Patients agree to receive standard care but using memsorb, the new CO2 filter evaluated in this study.
Device: memsorb
memsorb is a CO2 filter replacing current chemical CO2 absorbers




Primary Outcome Measures :
  1. End Tidal CO2 [ Time Frame: Up to 12h ]
    Concentration of carbon dioxide during expiratory cycle.


Other Outcome Measures:
  1. Fresh gas flow [ Time Frame: Up to 12h ]
    Analysis of fresh gas flow into the machine.

  2. Fractional concentration of inspired CO2 [ Time Frame: Up to 12h ]
    Analysis of concentration of CO2 during inspiratory cycle.

  3. Fractional concentration of inspired O2 [ Time Frame: Up to 12h ]
    Analysis of concentration of O2 in inspired gas.

  4. Arterial blood oxygen saturation [ Time Frame: Up to 12h ]
    Saturation of oxygen in arterial blood where measured by pulse oximetry and/or blood gas analysis.

  5. Arterial blood CO2 partial pressure [ Time Frame: Up to 12h ]
    Saturation of carbon dioxide in arterial blood measured by a blood gas analyzer.

  6. pH measurement [ Time Frame: Single collected measurement not more than 60 min after extubation ]
    pH of the condensed water in the drain valve and the PAL filter.

  7. Length of surgery [ Time Frame: Up to 12h ]
    Duration of surgical procedure.

  8. Ventilation frequency [ Time Frame: Up to 12h ]
    Measurement of patient breathing rate.

  9. Ventilation pressure [ Time Frame: Up to 12h ]
    Measurement of patient inspiratory pressure.

  10. Tidal volume [ Time Frame: Up to 12h ]
    Measurement of total lung volume as represented by the volume of air displaced between normal inhalation and exhalation.

  11. Patient temperature [ Time Frame: Up to 12h ]
    Body temperature of patient.

  12. Relaxation status [ Time Frame: Up to 12h ]
    Neuromuscular relaxation of patient.

  13. Heart rate [ Time Frame: Up to 12h ]
    Measurement and collection of patient heart rate.

  14. Blood pressure [ Time Frame: Up to 12h ]
    Measurement and collection of patient mean, systolic and diastolic blood pressure.

  15. Patient weight [ Time Frame: during preoperative assessment ]
    Weight of patient as collected from anaesthesia patient record database.

  16. Patient height [ Time Frame: during preoperative assessment ]
    Height of patient as collected from anaesthesia patient record database.

  17. Patient age [ Time Frame: during preoperative assessment ]
    Age of patient as collected from anaesthesia patient record database.

  18. Patient medications [ Time Frame: during preoperative assessment ]
    Medications being taken by patient as collected from anaesthesia patient record database.

  19. Lung disease [ Time Frame: during preoperative assessment ]
    Incidence of lung disease as collected from anaesthesia patient record database.

  20. Anaesthetic agent [ Time Frame: Up to 12h ]
    Inhaled and exhaled fraction of anaesthetic agent as collected from the anaesthetic patient record database



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists Physical Status Class I, II, III (low-medium risk patient)
  • English-speaking patients

Exclusion Criteria:

  • Self-reported as pregnant
  • American Society of Anesthesiologists Physical Status Class IV (high risk patient)
  • Patients scheduled for emergency surgery
  • Documented respiratory disease, including COPD and severe asthma
  • Documented elevated pressure in the brain (intra cranial pressure, ICP)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014336


Contacts
Layout table for location contacts
Contact: Katy Scurman (902) 221-0451 schurman@dmfmedical.com
Contact: Florentin Wilfart (902) 999-1781 wilfart@dmfmedical.com

Locations
Layout table for location information
Canada, Nova Scotia
Queen Elizabeth II HSC, Halifax Infirmary Site Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Orlando Hung, MD    (902)473-7736    orlando.hung@dal.ca   
Principal Investigator: Orlando Hung, MD         
Canada, Quebec
McGill University Health Centre Completed
Montréal, Quebec, Canada, H4A 3J1
Sponsors and Collaborators
DMF Medical Incorporated
Investigators
Layout table for investigator information
Principal Investigator: Orlando Hung, MD Nova Scotia Health Authority

Layout table for additonal information
Responsible Party: DMF Medical Incorporated
ClinicalTrials.gov Identifier: NCT03014336     History of Changes
Other Study ID Numbers: DMF-CLIN-16-01
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by DMF Medical Incorporated:
co2 removal, anesthesia

Additional relevant MeSH terms:
Layout table for MeSH terms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs