- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03014336
A New and Innovative Method for CO2 Removal in Anesthetic Circuits (memsorb)
A New and Innovative Method for CO2 Removal in Anesthetic Circuits: Replacing Chemical Granulate
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 3A7
- Queen Elizabeth II HSC, Halifax Infirmary Site
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- McGill University Health Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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.
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|
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Experimental: memsorb
Patients agree to receive standard care but using memsorb, the new CO2 filter evaluated in this study.
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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 Concentration (%)
Time Frame: From the start to the end of the intra-operative period for each participant
|
The mean concentration of carbon dioxide during the expiratory cycle, measured as a percentage (%), measured over the course of the surgical procedure.
|
From the start to the end of the intra-operative period for each participant
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fraction of Anaesthetic Agent (%)
Time Frame: From the start to the end of the intra-operative period for each participant
|
Inhaled and exhaled fraction of anaesthetic agent as collected from the anaesthetic patient record database.
Mean % inhalational anesthetic was calculated per surgical procedure.
Those means were used to calculate the overall mean
|
From the start to the end of the intra-operative period for each participant
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Orlando Hung, MD, Nova Scotia Health Authority
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DMF-CLIN-16-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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