Recruiting

Inhalational Anesthetic

Sponsor:

Western University, Canada

Code:

NCT04210570

Conditions

Anesthesia

Inhalation; Vapor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Memsorb

Chemical granulate absorber

Study Details

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 ID

NCT04210570

Start date

Mar 1, 2021

Status verified date

Feb, 2021

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Jul 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

510 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Memsorb GA

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

active comparator: CGA GA

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

experimental: Memsorb low-flow

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

experimental: CGA low flow

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

experimental: Memsorb laparoscopic surgery

Memsorb Filter will be used during general anesthesia for laparoscopic surgery

experimental: CGA laparoscopic surgery

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

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

Chemical granulate absorber

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

Primary outcome measure

  • Effectiveness of Memsorb compared to CGA to eliminate CO2 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Duration of general anesthesia (up to 12 hours) ]

Central Contacts and Locations

Central contacts

Locations

LHSC

Recruiting

London, Ontario, Canada, N6A 5A5

More Information

Sponsor

Western University, Canada

Last update posted

Mar 3, 2021

Last verified

Feb, 2021

Keywords

  • Anesthesia
  • Inhalation
  • Vapour
  • CO2 Absorber
  • Minimal Flow Anesthesia
  • Memsorb
  • Healthcare Cost
  • Greenhouse gas
  • Environment Healthcare

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2021-03-03.