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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients receive standard care with a standard CO2 absorber and agree to include their data in the study. | |
| memsorb | Experimental | Patients agree to receive standard care but using memsorb, the new CO2 filter evaluated in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| memsorb | Device | memsorb is a CO2 filter replacing current chemical CO2 absorbers |
|
| Measure | Description | Time Frame |
|---|---|---|
| End-tidal CO2 Concentration (%) | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Fraction of Anaesthetic Agent (%) | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Orlando Hung, MD | Nova Scotia Health Authority | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth II HSC, Halifax Infirmary Site | Halifax | Nova Scotia | B3H 3A7 | Canada | ||
| McGill University Health Centre |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Patients receive standard care with a standard CO2 absorber and agree to include their data in the study. |
| FG001 | Memsorb | Patients agree to receive standard care but using memsorb, the new CO2 filter evaluated in this study. memsorb: memsorb is a CO2 filter replacing current chemical CO2 absorbers |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Surgical patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Patients receive standard care with a standard CO2 absorber and agree to include their data in the study. |
| BG001 | Memsorb | Patients agree to receive standard care but using memsorb, the new CO2 filter evaluated in this study. memsorb: memsorb is a CO2 filter replacing current chemical CO2 absorbers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | End-tidal CO2 Concentration (%) | The mean concentration of carbon dioxide during the expiratory cycle, measured as a percentage (%), measured over the course of the surgical procedure. | Surgical participants. | Posted | Mean | Standard Deviation | % end-tidal CO2 | From the start to the end of the intra-operative period for each participant |
|
From the start to the end of the intra-operative period for each participant, an average of 1 hour.
The definitions of adverse event (AE) and serious adverse event (SAE) used in this study were consistent with the ClinicalTrials.gov definitions. AE data were collected only during the intra-operative period for each participant. No adverse events or serious adverse events were observed or reported during the study."
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Patients receive standard care with a standard CO2 absorber and agree to include their data in the study. |
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Early termination in McGill branch due to limited ability to recruit.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katy Schurman | DMF Medical Inc. | 902-221-0451 | schurman@dmfmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2021 | Jan 30, 2025 | Prot_SAP_000.pdf |
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| Montreal |
| Quebec |
| H4A 3J1 |
| Canada |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Other Pre-specified | Fraction of Anaesthetic Agent (%) | 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 | Posted | Mean | Standard Deviation | percentage of fractional anesthetic agen | From the start to the end of the intra-operative period for each participant |
|
|
|
| 0 |
| 111 |
| 0 |
| 111 |
| 0 |
| 111 |
| EG001 | Memsorb | Patients agree to receive standard care but using memsorb, the new CO2 filter evaluated in this study. memsorb: memsorb is a CO2 filter replacing current chemical CO2 absorbers | 0 | 175 | 0 | 175 | 0 | 175 |
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