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

November 18, 2022 updated by: DMF Medical Incorporated

A New and Innovative Method for CO2 Removal in Anesthetic Circuits:

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Recruiting
        • Queen Elizabeth II HSC, Halifax Infirmary Site
        • Contact:
        • Principal Investigator:
          • Orlando Hung, MD
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • Completed
        • McGill University Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
memsorb is a CO2 filter replacing current chemical CO2 absorbers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
End Tidal CO2
Time Frame: Up to 12h
Concentration of carbon dioxide during expiratory cycle.
Up to 12h

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fresh gas flow
Time Frame: Up to 12h
Analysis of fresh gas flow into the machine.
Up to 12h
Fractional concentration of inspired CO2
Time Frame: Up to 12h
Analysis of concentration of CO2 during inspiratory cycle.
Up to 12h
Fractional concentration of inspired O2
Time Frame: Up to 12h
Analysis of concentration of O2 in inspired gas.
Up to 12h
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.
Up to 12h
Arterial blood CO2 partial pressure
Time Frame: Up to 12h
Saturation of carbon dioxide in arterial blood measured by a blood gas analyzer.
Up to 12h
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.
Single collected measurement not more than 60 min after extubation
Length of surgery
Time Frame: Up to 12h
Duration of surgical procedure.
Up to 12h
Ventilation frequency
Time Frame: Up to 12h
Measurement of patient breathing rate.
Up to 12h
Ventilation pressure
Time Frame: Up to 12h
Measurement of patient inspiratory pressure.
Up to 12h
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.
Up to 12h
Patient temperature
Time Frame: Up to 12h
Body temperature of patient.
Up to 12h
Relaxation status
Time Frame: Up to 12h
Neuromuscular relaxation of patient.
Up to 12h
Heart rate
Time Frame: Up to 12h
Measurement and collection of patient heart rate.
Up to 12h
Blood pressure
Time Frame: Up to 12h
Measurement and collection of patient mean, systolic and diastolic blood pressure.
Up to 12h
Patient weight
Time Frame: during preoperative assessment
Weight of patient as collected from anaesthesia patient record database.
during preoperative assessment
Patient height
Time Frame: during preoperative assessment
Height of patient as collected from anaesthesia patient record database.
during preoperative assessment
Patient age
Time Frame: during preoperative assessment
Age of patient as collected from anaesthesia patient record database.
during preoperative assessment
Patient medications
Time Frame: during preoperative assessment
Medications being taken by patient as collected from anaesthesia patient record database.
during preoperative assessment
Lung disease
Time Frame: during preoperative assessment
Incidence of lung disease as collected from anaesthesia patient record database.
during preoperative assessment
Anaesthetic agent
Time Frame: Up to 12h
Inhaled and exhaled fraction of anaesthetic agent as collected from the anaesthetic patient record database
Up to 12h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

October 12, 2016

First Submitted That Met QC Criteria

January 5, 2017

First Posted (Estimate)

January 9, 2017

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 18, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • DMF-CLIN-16-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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