Memsorb Filter System for Anesthesia Environmental Impact

Overseen By Ruediger Noppens, MD, PhD, FRCPC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Severe respiratory disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Up to 12 hours per procedure

510 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests Memsorb, a new device that removes CO2 from anesthesia systems without harmful chemicals. It targets patients in busy surgical centers to reduce costs and environmental impact. Memsorb works by letting CO2 out but keeping anesthetic gases in, making it safer and more efficient.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Memsorb Filter System treatment for reducing the environmental impact of anesthesia?

The Memsorb Filter System, which uses a semipermeable membrane to remove carbon dioxide from anesthesia circuits, was shown to perform effectively in a high-fidelity lung simulator, suggesting it could be a viable alternative to traditional chemical granulate absorbers for reducing environmental impact. ^{1 2 3 4 5}

Is the Memsorb Filter System safe for use in humans?

The Memsorb Filter System, a device for removing carbon dioxide during anesthesia, has been tested in laboratory settings and compared to standard chemical absorbers. While these studies focus on performance rather than direct human safety, they suggest that the device functions effectively without indicating any specific safety concerns. ^{1 6 7 8 9}

How does the Memsorb treatment differ from other treatments for reducing anesthesia's environmental impact?

The Memsorb Filter System is unique because it uses microporous membranes to selectively remove endotoxins, which are harmful substances, from solutions. This approach is different from traditional methods as it focuses on adsorption (a process where molecules stick to a surface) to purify substances, potentially reducing the environmental impact of anesthesia by filtering out contaminants. ^{10 11 12 13 14}

Eligibility Criteria

This trial is for patients undergoing elective surgery, specifically laparoscopic for one part of the study. They should have a physical status classification of ASA I to III, meaning they range from healthy to having some severe disease but not incapacitated. It's not for those with high intracranial pressure, very severe systemic disease (ASA > IV), emergencies, severe respiratory issues like asthma, pregnant individuals or surgeries using regional anesthesia.

Inclusion Criteria

Elective surgical procedure

You have had laparoscopic surgery for the purpose of study aim III.

You are classified as having a low to moderate overall health status.

Exclusion Criteria

You have high pressure inside your brain.

You are pregnant, based on your own report.

Emergency surgery

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo general anesthesia using either Memsorb or CGA systems during various surgical procedures

Up to 12 hours per procedure

1 visit per surgical procedure

Follow-up

Participants are monitored for safety and effectiveness after anesthesia

4 weeks

Treatment Details

Interventions

• Chemical granulate absorber
• Memsorb

Trial Overview The trial is testing Memsorb, a new CO2 membrane filter system against traditional chemical granulate absorbers (CGAs) used during anesthesia in surgeries. The goal is to see if Memsorb can effectively remove CO2 and maintain proper ventilation while reducing anesthetic gas use and environmental impact compared to CGAs.

Participant Groups

Group I: Memsorb low-flow Experimental Treatment 1 Intervention

Memsorb Filter will be used during low flow general anesthesia (GA)

Group II: Memsorb laparoscopic surgery Experimental Treatment 1 Intervention

Memsorb Filter will be used during general anesthesia for laparoscopic surgery

Group III: Memsorb GA Experimental Treatment 1 Intervention

Memsorb Filter will be used during general anesthesia (GA), fresh gas flow and ventilator settings are not modified

Group IV: CGA low flow Experimental Treatment 1 Intervention

Chemical CO2 absorber (CGA) will be used during low flow general anesthesia (GA)

Group V: CGA laparoscopic surgery Experimental Treatment 1 Intervention

Chemical CO2 absorber (CGA) will be used during laparoscopic surgery

Group VI: CGA GA Active Control 1 Intervention

Chemical CO2 absorber (CGA) will be used during general anesthesia (GA), fresh gas flow and ventilator settings are not modified

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Findings from Research

The low-volume anesthesia machine (Maquet Flow-i C20) delivered approximately 20% less sevoflurane compared to the traditional anesthesia machine (GE Aisys CS2), indicating greater efficiency in volatile anesthetic delivery during surgery.

Using the MQ machine not only reduces anesthetic costs, potentially saving around $239,440 over 10 years, but also significantly lowers CO2 emissions by 201 metric tons, highlighting its environmental benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Environmental and Economic Impact of Using a Higher Efficiency Ventilator and Vaporizer During Surgery Under General Anesthesia: A Randomized Controlled Prospective Cohort. Field, RR., Calderon, MC., Ronilo, SM., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of the novel membrane-based carbon dioxide filter memsorb™ with a chemical granulate absorbent using a high-fidelity lung simulator: a prospective randomized in vitro trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Technical communication: An initial evaluation of a novel anesthetic scavenging interface. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Environmental and Economic Impact of Using a Higher Efficiency Ventilator and Vaporizer During Surgery Under General Anesthesia: A Randomized Controlled Prospective Cohort. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of three commercially available activated charcoal canisters for passive scavenging of waste isoflurane during conventional rodent anesthesia. [2016]

5. Germany pubmed.ncbi.nlm.nih.gov

[Environmentally friendly absorption of anesthetic gases : First experiences with a commercial anesthetic gas capture system]. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Water Pollution and Environmental Concerns in Anesthesiology. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Memsorb™, a novel CO2 removal device part I: in vitro performance with the Zeus IE®. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Technical communication: the effect of the double mask on anesthetic waste gas levels during pediatric mask inductions in dental offices. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Environmental risk assessment of propofol in wastewater: a narrative review of regulatory guidelines. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Endotoxin removal from albumin and saline solutions. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Development of cationically modified cellulose adsorbents for the removal of endotoxins. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Microspheres based detoxification system: a new method in convective blood purification. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Evaluation of endotoxin retention by adsorptive-based filtration media. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Endotoxin adsorbents in extracorporeal blood purification: do they fulfill expectations? [2017]