AnesthesiaNCT04210570
Decreasing Environmental Impact and Costs of Using Inhalational Anesthetic With a Carbon Dioxide Membrane Filter System
A study testing Memsorb and Chemical granulate absorber in people with Anesthesia and Inhalation; Vapor, run by Western University, Canada at 1 site in Canada.
Trial summary
Efficient inhalational anesthetic delivery requires the use of low-flow air and oxygen to reduce drug waste and minimize workspace contamination and environmental pollution. Currently, excess anesthetic gas is scavenged and removed from the operating room via the hospital ventilation system, where it is released into… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Inhalation; Vapor
- What is being tested?
- Memsorb and Chemical granulate absorber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I - III
- Elective surgical procedure
- Laparoscopic surgery for study aim III
Who cannot join
- ASA > IV
- Emergency surgery
- Severe respiratory disease (eg Asthma)
- Raised intracranial pressure
- Regional anesthesia
- Absence of arterial line for study aim III
- Self-reported pregnancy
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
LHSC
London, Ontario, N6A 5A5
Ruediger Noppens
About this study
Official title: Decreasing Environmental Impact and Costs of Using Inhalational Anesthetics by Replacing Chemical Absorbers With an Innovative Carbon Dioxide Membrane Filter System - a Prospective, Randomized, Clinical Trial
Efficient inhalational anesthetic delivery requires the use of low-flow air and oxygen to reduce drug waste and minimize workspace contamination and environmental pollution. Currently, excess anesthetic gas is scavenged and removed from the operating room via the hospital ventilation system, where it is released into the atmosphere. CO2 is removed from the anesthesia circuit by the use of CO2 removal systems to prevent re-breathing and potential hypercarbia.
Carbon dioxide is currently removed using chemical granulate absorbers (CGAs), which trap CO2 in the granules that are later disposed of when absorption capacity is reached. They require replacement approximately every other day when used in moderate to high volume surgical centres, placing a costly burden on the healthcare system and environment (landfill).
Read more
One of the more concerning downfalls of using CGAs is the potential for the inhalational anesthetics to react with the granules and potentially produce toxic byproducts known as compounds A-E that are nephrotoxic and neurotoxic and require excess amounts of anesthetic gas to dilute.
This excess use of anesthetics gases places a financial burden on the healthcare system and has a detrimental impact on the environment. The vast majority of the gases used are eventually released into the environment with little to no degradation where they accumulate in the troposphere and act as greenhouse gases.
DMF Medical has created Memsorb, a new CO2 filtration membrane. Memsorb can remove CO2 from the anesthesia circuit without the use of CGAs, thereby eliminating the potential for toxic byproducts and allowing for significantly lower air and oxygen flow to be used, resulting in less use of inhalational anesthetics. Memsorb uses a polymeric membrane (similar to the ones used in oxygenators for cardiac surgery) that selectively allows CO2 to leave the rebreathing system, while maintaining the inhalational anesthetic in the circuit.
The lifespan of Memsorb is at least 12 months, resulting in less particulate waste and a decreased cost to the healthcare system.
We wish to evaluate the ability and efficacy of Memsorb in removing CO2 from the anesthesia circuit while maintaining physiologic minute volume ventilation, as compared to the traditional CGAs in a variety of surgical procedures, patient populations, and anesthesia gas flows.
- Conditions
- Anesthesia, Inhalation; Vapor
- Being tested
- Memsorb, Chemical granulate absorber
- Keywords
- Anesthesia, Inhalation, Vapour, CO2 Absorber, Minimal Flow Anesthesia, Memsorb, Healthcare Cost, Greenhouse gas, Environment Healthcare
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemsorbDevice
Memsorb uses a polymeric membrane (similar to the ones used in oxygenators for cardiac surgery) that selectively allows CO2 to leave the rebreathing system while maintaining the inhalational anesthetic in the anesthesia circuit
Chemical granulate absorberDrug
Chemical granulate absorber trap CO2 chemically in granules that are later disposed of when absorption capacity is reached
| Study group | Role | What they receive |
|---|---|---|
| Memsorb GA | Experimental | Memsorb Filter will be used during general anesthesia (GA), fresh gas flow and ventilator settings are not modified Receives: Device: Memsorb |
| CGA GA | Active comparator | Chemical CO2 absorber (CGA) will be used during general anesthesia (GA), fresh gas flow and ventilator settings are not modified Receives: Drug: Chemical granulate absorber |
| Memsorb low-flow | Experimental | Memsorb Filter will be used during low flow general anesthesia (GA) Receives: Device: Memsorb |
| CGA low flow | Experimental | Chemical CO2 absorber (CGA) will be used during low flow general anesthesia (GA) Receives: Drug: Chemical granulate absorber |
| Memsorb laparoscopic surgery | Experimental | Memsorb Filter will be used during general anesthesia for laparoscopic surgery Receives: Device: Memsorb |
| CGA laparoscopic surgery | Experimental | Chemical CO2 absorber (CGA) will be used during laparoscopic surgery Receives: Drug: Chemical granulate absorber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Memsorb compared to CGA to eliminate CO2
etCO2 (mmHg) and tidal volumes (ml) will be measured with the two systems in GE / Dates Ohmeda anesthesia machines
Measured: Duration of general anesthesia (up to 12 hours)
Impact of Memsorb, using minimal flow anesthesia (≤ 0.50 L/min), on the amount of inhalational anesthetic (ml) used, compared to standard practice
Usage of Desflurane in ml will be measured during minimal flow (≤ 0.5 L/min) anesthesia, compared to traditional higher gas flow (> 2 L/min).
Measured: Duration of general anesthesia (up to 12 hours)
Effectiveness of using Memsorb during ventilation for removal of CO2 in laparoscopic surgeries resulting in high CO2 exposure, compared to CGAs
etCO2 (mmHg), paCO2 (mmHg) and tidal volumes (ml) needed remove CO2 during laparoscopic surgery, resulting in higher CO2 exposure.
Measured: Duration of general anesthesia (up to 12 hours)
Secondary outcomes (6)
Amount of inhaled anesthetics used
Usage on inhaled anesthetics in ml for the surgery.
Measured: Duration of general anesthesia (up to 12 hours)
Duration of anesthesia
Durantion measured in minutes
Measured: Duration of general anesthesia (up to 12 hours)
Water build up in anesthesia circuit
Likert scale to measure water build up (1- no water, 3 - large amount of water)
Measured: Duration of general anesthesia (up to 12 hours)
Freshgas flow during general anesthesia
Measured in ml/min
Measured: Duration of general anesthesia (up to 12 hours)
Number of CGAs used during the study period
absolute number of canisters used
Measured: Duration of general anesthesia (up to 12 hours)
Minute volume ventilation
tidal volume (ml) x respiratory rate (/min)
Measured: Duration of general anesthesia (up to 12 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start1 Mar 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210570
- Sponsor's protocol ID
- 114511
- Status last verified
- Feb 2021
- First submitted
- 25 Nov 2019
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Environmental Impact and Costs of Using Inhalational Anesthetics by Replacing Chemical Absorbers With an Innovative Carbon Dioxide Membrane Filter System - a Prospective, Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT04210570
- Acronym / sponsor ID
- 114511
- Conditions
- Anesthesia, Inhalation; Vapor
- Keywords
- Anesthesia, Inhalation, Vapour, CO2 Absorber, Minimal Flow Anesthesia, Memsorb, Healthcare Cost, Greenhouse gas
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficient inhalational anesthetic delivery requires the use of low-flow air and oxygen to reduce drug waste and minimize workspace contamination and environmental pollution. Currently, excess anesthetic gas is scavenged and removed from the operating room via the hospital ventilation system, where it is released into the atmosphere. CO2 is removed from the anesthesia circuit by the use of CO2 removal systems to prevent re-breathing and potential hypercarbia.
Carbon dioxide is currently removed using chemical granulate absorbers (CGAs), which trap CO2 in the granules that are later disposed of when absorption capacity is reached. They require replacement approximately every other day when used in moderate to high volume surgical centres, placing a costly burden on the healthcare system and environment (landfill).
One of the more concerning downfalls of using CGAs is the potential for the inhalational anesthetics to react with the granules and potentially produce toxic byproducts known as compounds A-E that are nephrotoxic and neurotoxic and require excess amounts of anesthetic gas to dilute.
This excess use of anesthetics gases places a financial burden on the healthcare system and has a detrimental impact on the environment. The vast majority of the gases used are eventually released into the environment with little to no degradation where they accumulate in the troposphere and act as greenhouse gases.
DMF Medical has created Memsorb, a new CO2 filtration membrane. Memsorb can remove CO2 from the anesthesia circuit without the use of CGAs, thereby eliminating the potential for toxic byproducts and allowing for significantly lower air and oxygen flow to be used, resulting in less use of inhalational anesthetics. Memsorb uses a polymeric membrane (similar to the ones used in oxygenators for cardiac surgery) that selectively allows CO2 to leave the rebreathing system, while maintaining the inhalational anesthetic in the circuit.
The lifespan of Memsorb is at least 12 months, resulting in less particulate waste and a decreased cost to the healthcare system.
We wish to evaluate the ability and efficacy of Memsorb in removing CO2 from the anesthesia circuit while maintaining physiologic minute volume ventilation, as compared to the traditional CGAs in a variety of surgical procedures, patient populations, and anesthesia gas flows.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Memsorb GA | Experimental | Device: MemsorbMemsorb Filter will be used during general anesthesia (GA), fresh gas flow and ventilator settings are not modified |
| CGA GA | Active comparator | Drug: Chemical granulate absorberChemical CO2 absorber (CGA) will be used during general anesthesia (GA), fresh gas flow and ventilator settings are not modified |
| Memsorb low-flow | Experimental | Device: MemsorbMemsorb Filter will be used during low flow general anesthesia (GA) |
| CGA low flow | Experimental | Drug: Chemical granulate absorberChemical CO2 absorber (CGA) will be used during low flow general anesthesia (GA) |
| Memsorb laparoscopic surgery | Experimental | Device: MemsorbMemsorb Filter will be used during general anesthesia for laparoscopic surgery |
| CGA laparoscopic surgery | Experimental | Drug: Chemical granulate absorberChemical CO2 absorber (CGA) will be used during laparoscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I - III
- Elective surgical procedure
- Laparoscopic surgery for study aim III
Key exclusion criteria (7 listed)
- ASA > IV
- Emergency surgery
- Severe respiratory disease (eg Asthma)
- Raised intracranial pressure
- Regional anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MemsorbMemsorb uses a polymeric membrane (similar to the ones used in oxygenators for cardiac surgery) that selectively allows CO2 to leave the rebreathing system while maintaining the inhalational anesthetic in the anesthesia circuit | Device | Memsorb GA, Memsorb laparoscopic surgery, Memsorb low-flow |
| Chemical granulate absorberChemical granulate absorber trap CO2 chemically in granules that are later disposed of when absorption capacity is reached | Drug | CGA GA, CGA laparoscopic surgery, CGA low flow |
Primary outcome
Effectiveness of Memsorb compared to CGA to eliminate CO2
Time frame: Duration of general anesthesia (up to 12 hours)
etCO2 (mmHg) and tidal volumes (ml) will be measured with the two systems in GE / Dates Ohmeda anesthesia machines
Impact of Memsorb, using minimal flow anesthesia (≤ 0.50 L/min), on the amount of inhalational anesthetic (ml) used, compared to standard practice
Time frame: Duration of general anesthesia (up to 12 hours)
Usage of Desflurane in ml will be measured during minimal flow (≤ 0.5 L/min) anesthesia, compared to traditional higher gas flow (> 2 L/min).
Effectiveness of using Memsorb during ventilation for removal of CO2 in laparoscopic surgeries resulting in high CO2 exposure, compared to CGAs
Time frame: Duration of general anesthesia (up to 12 hours)
etCO2 (mmHg), paCO2 (mmHg) and tidal volumes (ml) needed remove CO2 during laparoscopic surgery, resulting in higher CO2 exposure.
6 secondary outcomes
Amount of inhaled anesthetics used
Time frame: Duration of general anesthesia (up to 12 hours)
Duration of anesthesia
Time frame: Duration of general anesthesia (up to 12 hours)
Water build up in anesthesia circuit
Time frame: Duration of general anesthesia (up to 12 hours)
Freshgas flow during general anesthesia
Time frame: Duration of general anesthesia (up to 12 hours)
Number of CGAs used during the study period
Time frame: Duration of general anesthesia (up to 12 hours)
Minute volume ventilation
Time frame: Duration of general anesthesia (up to 12 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memsorb and Chemical granulate absorber in people with Anesthesia and Inhalation; Vapor, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruediger Noppens, MD, PhD, FRCPC (519) 685-8500 ext. 35111, ruediger.noppens@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Memsorb compared to CGA to eliminate CO2 (time frame: Duration of general anesthesia (up to 12 hours)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.