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

Primary Purpose

Anesthesia, Inhalation; Vapor

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Memsorb
Chemical granulate absorber
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Anesthesia focused on measuring Anesthesia, Inhalation, Vapour, CO2 Absorber, Minimal Flow Anesthesia, Memsorb, Healthcare Cost, Greenhouse gas, Environment Healthcare

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LHSCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Memsorb GA

CGA GA

Memsorb low-flow

CGA low flow

Memsorb laparoscopic surgery

CGA laparoscopic surgery

Arm Description

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

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

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

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

Memsorb Filter will be used during general anesthesia for laparoscopic surgery

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

Outcomes

Primary Outcome Measures

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
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).
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.

Secondary Outcome Measures

Amount of inhaled anesthetics used
Usage on inhaled anesthetics in ml for the surgery.
Duration of anesthesia
Durantion measured in minutes
Water build up in anesthesia circuit
Likert scale to measure water build up (1- no water, 3 - large amount of water)
Freshgas flow during general anesthesia
Measured in ml/min
Number of CGAs used during the study period
absolute number of canisters used
Minute volume ventilation
tidal volume (ml) x respiratory rate (/min)

Full Information

First Posted
November 25, 2019
Last Updated
March 1, 2021
Sponsor
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT04210570
Brief Title
Decreasing Environmental Impact and Costs of Using Inhalational Anesthetic With a Carbon Dioxide Membrane Filter System
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Inhalation; Vapor
Keywords
Anesthesia, Inhalation, Vapour, CO2 Absorber, Minimal Flow Anesthesia, Memsorb, Healthcare Cost, Greenhouse gas, Environment Healthcare

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
510 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Memsorb GA
Arm Type
Experimental
Arm Description
Memsorb Filter will be used during general anesthesia (GA), fresh gas flow and ventilator settings are not modified
Arm Title
CGA GA
Arm Type
Active Comparator
Arm Description
Chemical CO2 absorber (CGA) will be used during general anesthesia (GA), fresh gas flow and ventilator settings are not modified
Arm Title
Memsorb low-flow
Arm Type
Experimental
Arm Description
Memsorb Filter will be used during low flow general anesthesia (GA)
Arm Title
CGA low flow
Arm Type
Experimental
Arm Description
Chemical CO2 absorber (CGA) will be used during low flow general anesthesia (GA)
Arm Title
Memsorb laparoscopic surgery
Arm Type
Experimental
Arm Description
Memsorb Filter will be used during general anesthesia for laparoscopic surgery
Arm Title
CGA laparoscopic surgery
Arm Type
Experimental
Arm Description
Chemical CO2 absorber (CGA) will be used during laparoscopic surgery
Intervention Type
Device
Intervention Name(s)
Memsorb
Intervention Description
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
Drug
Intervention Name(s)
Chemical granulate absorber
Intervention Description
Chemical granulate absorber trap CO2 chemically in granules that are later disposed of when absorption capacity is reached
Primary Outcome Measure Information:
Title
Effectiveness of Memsorb compared to CGA to eliminate CO2
Description
etCO2 (mmHg) and tidal volumes (ml) will be measured with the two systems in GE / Dates Ohmeda anesthesia machines
Time Frame
Duration of general anesthesia (up to 12 hours)
Title
Impact of Memsorb, using minimal flow anesthesia (≤ 0.50 L/min), on the amount of inhalational anesthetic (ml) used, compared to standard practice
Description
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).
Time Frame
Duration of general anesthesia (up to 12 hours)
Title
Effectiveness of using Memsorb during ventilation for removal of CO2 in laparoscopic surgeries resulting in high CO2 exposure, compared to CGAs
Description
etCO2 (mmHg), paCO2 (mmHg) and tidal volumes (ml) needed remove CO2 during laparoscopic surgery, resulting in higher CO2 exposure.
Time Frame
Duration of general anesthesia (up to 12 hours)
Secondary Outcome Measure Information:
Title
Amount of inhaled anesthetics used
Description
Usage on inhaled anesthetics in ml for the surgery.
Time Frame
Duration of general anesthesia (up to 12 hours)
Title
Duration of anesthesia
Description
Durantion measured in minutes
Time Frame
Duration of general anesthesia (up to 12 hours)
Title
Water build up in anesthesia circuit
Description
Likert scale to measure water build up (1- no water, 3 - large amount of water)
Time Frame
Duration of general anesthesia (up to 12 hours)
Title
Freshgas flow during general anesthesia
Description
Measured in ml/min
Time Frame
Duration of general anesthesia (up to 12 hours)
Title
Number of CGAs used during the study period
Description
absolute number of canisters used
Time Frame
Duration of general anesthesia (up to 12 hours)
Title
Minute volume ventilation
Description
tidal volume (ml) x respiratory rate (/min)
Time Frame
Duration of general anesthesia (up to 12 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruediger Noppens, MD, PhD, FRCPC
Phone
519) 685-8500
Ext
35111
Email
ruediger.noppens@lhsc.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Lee-Anne Focesato
Phone
519 685-8500
Email
LeeAnne.Fochesato@lhsc.on.ca
Facility Information:
Facility Name
LHSC
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruediger Noppens

12. IPD Sharing Statement

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

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