Decreasing Environmental Impact and Costs of Using Inhalational Anesthetic With a Carbon Dioxide Membrane Filter System

NCT ID: NCT04210570

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 510 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-12-31

Brief 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 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.

Conditions

Anesthesia; Inhalation; Vapor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Memsorb GA

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

Group Type: EXPERIMENTAL

Memsorb

Intervention Type: DEVICE

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

CGA GA

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

Group Type: ACTIVE_COMPARATOR

Chemical granulate absorber

Intervention Type: DRUG

Chemical granulate absorber trap CO2 chemically in granules that are later disposed of when absorption capacity is reached

Memsorb low-flow

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

Group Type: EXPERIMENTAL

Memsorb

Intervention Type: DEVICE

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

CGA low flow

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

Group Type: EXPERIMENTAL

Chemical granulate absorber

Intervention Type: DRUG

Chemical granulate absorber trap CO2 chemically in granules that are later disposed of when absorption capacity is reached

Memsorb laparoscopic surgery

Memsorb Filter will be used during general anesthesia for laparoscopic surgery

Group Type: EXPERIMENTAL

Memsorb

Intervention Type: DEVICE

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

CGA laparoscopic surgery

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

Group Type: EXPERIMENTAL

Chemical granulate absorber

Intervention Type: DRUG

Chemical granulate absorber trap CO2 chemically in granules that are later disposed of when absorption capacity is reached

Interventions

Memsorb

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

Intervention Type: DEVICE

Chemical granulate absorber

Chemical granulate absorber trap CO2 chemically in granules that are later disposed of when absorption capacity is reached

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• ASA I - III
• Elective surgical procedure
• Laparoscopic surgery for study aim III

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

LHSC

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Ruediger Noppens, MD, PhD, FRCPC

Role: CONTACT

ruediger.noppens@lhsc.on.ca

519) 685-8500 ext. 35111

Lee-Anne Focesato

Role: CONTACT

LeeAnne.Fochesato@lhsc.on.ca

519 685-8500

Facility Contacts

Ruediger Noppens

Role: primary

Other Identifiers

114511

Identifier Type: -

Identifier Source: org_study_id