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

Sponsor
DMF Medical Incorporated (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03014336
Collaborator
(none)
450
2
2
44
225
5.1

Study Details

Study Description

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
  • Device: memsorb
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2017
Anticipated Primary Completion Date :
Jun 1, 2020
Anticipated Study Completion Date :
Sep 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. End Tidal CO2 [Up to 12h]

    Concentration of carbon dioxide during expiratory cycle.

Other Outcome Measures

  1. Fresh gas flow [Up to 12h]

    Analysis of fresh gas flow into the machine.

  2. Fractional concentration of inspired CO2 [Up to 12h]

    Analysis of concentration of CO2 during inspiratory cycle.

  3. Fractional concentration of inspired O2 [Up to 12h]

    Analysis of concentration of O2 in inspired gas.

  4. Arterial blood oxygen saturation [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 [Up to 12h]

    Saturation of carbon dioxide in arterial blood measured by a blood gas analyzer.

  6. pH measurement [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 [Up to 12h]

    Duration of surgical procedure.

  8. Ventilation frequency [Up to 12h]

    Measurement of patient breathing rate.

  9. Ventilation pressure [Up to 12h]

    Measurement of patient inspiratory pressure.

  10. Tidal volume [Up to 12h]

    Measurement of total lung volume as represented by the volume of air displaced between normal inhalation and exhalation.

  11. Patient temperature [Up to 12h]

    Body temperature of patient.

  12. Relaxation status [Up to 12h]

    Neuromuscular relaxation of patient.

  13. Heart rate [Up to 12h]

    Measurement and collection of patient heart rate.

  14. Blood pressure [Up to 12h]

    Measurement and collection of patient mean, systolic and diastolic blood pressure.

  15. Patient weight [during preoperative assessment]

    Weight of patient as collected from anaesthesia patient record database.

  16. Patient height [during preoperative assessment]

    Height of patient as collected from anaesthesia patient record database.

  17. Patient age [during preoperative assessment]

    Age of patient as collected from anaesthesia patient record database.

  18. Patient medications [during preoperative assessment]

    Medications being taken by patient as collected from anaesthesia patient record database.

  19. Lung disease [during preoperative assessment]

    Incidence of lung disease as collected from anaesthesia patient record database.

  20. Anaesthetic agent [Up to 12h]

    Inhaled and exhaled fraction of anaesthetic agent as collected from the anaesthetic patient record database

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Queen Elizabeth II HSC, Halifax Infirmary Site Halifax Nova Scotia Canada B3H 3A7
2 McGill University Health Centre Montréal Quebec Canada H4A 3J1

Sponsors and Collaborators

  • DMF Medical Incorporated

Investigators

  • Principal Investigator: Orlando Hung, MD, Nova Scotia Health Authority

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
DMF Medical Incorporated
ClinicalTrials.gov Identifier:
NCT03014336
Other Study ID Numbers:
  • DMF-CLIN-16-01
First Posted:
Jan 9, 2017
Last Update Posted:
Jan 9, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by DMF Medical Incorporated

Study Results

No Results Posted as of Jan 9, 2020