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

NCT04210570 | Unknown

• 1 other identifier: 114511
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

  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).

  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.

  Duration of general anesthesia (up to 12 hours)

Secondary Outcomes (6)

• Amount of inhaled anesthetics used

  Duration of general anesthesia (up to 12 hours)

• Duration of anesthesia

  Duration of general anesthesia (up to 12 hours)

• Water build up in anesthesia circuit

  Duration of general anesthesia (up to 12 hours)

• Freshgas flow during general anesthesia

  Duration of general anesthesia (up to 12 hours)

• Number of CGAs used during the study period

  Duration of general anesthesia (up to 12 hours)

Study Arms (6)

Memsorb GA

EXPERIMENTAL

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

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

Drug: Chemical granulate absorber

Memsorb low-flow

EXPERIMENTAL

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

Device: Memsorb

CGA low flow

EXPERIMENTAL

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

Drug: Chemical granulate absorber

Memsorb laparoscopic surgery

EXPERIMENTAL

Memsorb Filter will be used during general anesthesia for laparoscopic surgery

Device: Memsorb

CGA laparoscopic surgery

EXPERIMENTAL

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

Drug: Chemical granulate absorber

Interventions

Memsorb 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

Memsorb GA; Memsorb laparoscopic surgery; Memsorb low-flow

Chemical granulate absorber DRUG

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

CGA GA; CGA laparoscopic surgery; CGA low flow

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

LHSC

London, Ontario, N6A 5A5, Canada

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ruediger Noppens, MD, PhD, FRCPC

CONTACT

519) 685-8500; ruediger.noppens@lhsc.on.ca

Lee-Anne Focesato

CONTACT

519 685-8500; LeeAnne.Fochesato@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 24, 2019
• Study Start: March 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: December 31, 2023
• Last Updated: March 3, 2021

Record last verified: 2021-02

Locations

CA (1)