What side effects are associated with this type of intervention?

Common treatments for anesthesia, particularly those involving inhalational anesthetics, can have side effects such as nausea, vomiting, respiratory depression, and hypotension. Traditional CO2 removal systems using chemical granulate absorbers (CGAs) can produce toxic byproducts that are nephrotoxic and neurotoxic, and they require frequent replacement, contributing to environmental waste. The Memsorb system, which uses a polymeric membrane for CO2 filtration, aims to reduce these risks by eliminating the production of toxic byproducts and decreasing environmental impact.

What prior FDA approvals exist?

The FDA has approved various inhalational anesthetics such as sevoflurane and desflurane, which are commonly used in surgical procedures. Traditional CO2 removal systems in anesthesia circuits typically use chemical granulate absorbers (CGAs) to prevent re-breathing and potential hypercarbia. However, these systems can produce toxic byproducts and require frequent replacement. A new system, Memsorb, utilizes a polymeric membrane to filter CO2 without generating toxic byproducts, allowing for more efficient use of anesthetic gases and reducing environmental impact. This innovation represents a significant advancement in anesthesia technology.

What other types of research exist?

As of 2024, promising alternatives to Memsorb for CO2 filtration in anesthesia patients include advanced chemical granulate absorbers (CGAs) with improved formulations to reduce toxic byproducts, and emerging technologies such as solid amine-based CO2 scrubbers and metal-organic frameworks (MOFs) that offer high CO2 absorption capacity and lower environmental impact. Additionally, innovations in low-flow anesthesia systems and closed-loop anesthesia delivery systems are being developed to enhance efficiency and reduce anesthetic gas waste.

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Carbon Dioxide Filtration Membrane

Memsorb Filter System for Anesthesia Environmental Impact

N/A

Waitlist Available

Research Sponsored by Western University, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of general anesthesia (up to 12 hours)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed for this device trial, potential risks may include inadequate removal of CO2 leading to hypercarbia or insufficient anesthetic delivery; however these will be monitored closely during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of general anesthesia (up to 12 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration of general anesthesia (up to 12 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of general anesthesia (up to 12 hours) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effectiveness of Memsorb compared to CGA to eliminate CO2

Effectiveness of using Memsorb during ventilation for removal of CO2 in laparoscopic surgeries resulting in high CO2 exposure, compared to CGAs

Anesthesia procedures

Secondary study objectives

Amount of inhaled anesthetics used

Duration of anesthesia

Freshgas flow during general anesthesia

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Memsorb low-flowExperimental Treatment1 Intervention

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

Group II: Memsorb laparoscopic surgeryExperimental Treatment1 Intervention

Memsorb Filter will be used during general anesthesia for laparoscopic surgery

Group III: Memsorb GAExperimental Treatment1 Intervention

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

Group IV: CGA low flowExperimental Treatment1 Intervention

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

Group V: CGA laparoscopic surgeryExperimental Treatment1 Intervention

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

Group VI: CGA GAActive Control1 Intervention

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for anesthesia include inhalational anesthetics, which work by depressing the central nervous system to induce unconsciousness and analgesia. These agents are typically delivered through a breathing circuit, where carbon dioxide (CO2) is removed to prevent hypercarbia. Traditional CO2 removal systems use chemical granulate absorbers (CGAs), which can produce toxic byproducts and require frequent replacement. Memsorb, a polymeric membrane for CO2 filtration, offers a novel approach by selectively removing CO2 without generating harmful byproducts, thus reducing environmental impact and healthcare costs. This matters for anesthesia patients as it ensures safer, more efficient anesthesia delivery with fewer side effects and lower risk of complications.

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