A New and Innovative Method for CO2 Removal in Anesthetic Circuits: Replacing Chemical Granulate

Anesthesia Clinical Trial

— memsorb  

Official title:

A New and Innovative Method for CO2 Removal in Anesthetic Circuits:

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03014336
• Other study ID #: DMF-CLIN-16-01
• Status: Recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: June 2025

Study information

• Verified date: November 2022
• Source: DMF Medical Incorporated
• Contact: Katy Scurman
• Phone: (902) 221-0451
• Email: schurman[@]dmfmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The drawbacks of chemical CO2 absorbers include the production of compounds harmful to patients that also lead into increased cost and environmental impact, as well as the daily disposal of compound special waste. Sustainable management of general anesthesia is a growing concern. Continually diluting anesthetic circuits, and the disposal of chemical granulate are serious environmental problems.

Description:

DMF Medical has developed a next-generation CO2 filter in order to address the safety issues with current chemical CO2 absorbers in anesthesia.

memsorb uses patented advanced medical membrane technology to filter CO2 from anesthetic circuits rather than absorbing via a chemical reaction.

This game changing technology relies on a polymeric membrane core (similar to the ones used in oxygenators for cardiac surgery) that selectively allows CO2 to leave the rebreathing system, while maintaining the anesthetic vapor in the circuit.

memsorb is a cartridge similar in size and shape to current solutions that simply clicks in place.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists Physical Status Class I, II, III (low-medium risk patient)

• English-speaking patients

Exclusion Criteria:

• Self-reported as pregnant

• American Society of Anesthesiologists Physical Status Class IV (high risk patient)

• Patients scheduled for emergency surgery

• Documented respiratory disease, including COPD and severe asthma

• Documented elevated pressure in the brain (intra cranial pressure, ICP)

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• memsorb
memsorb is a CO2 filter replacing current chemical CO2 absorbers

Locations

Country	Name	City	State
Canada	Queen Elizabeth II HSC, Halifax Infirmary Site	Halifax	Nova Scotia
Canada	McGill University Health Centre	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
DMF Medical Incorporated

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fresh gas flow	Analysis of fresh gas flow into the machine.	Up to 12h
Other	Fractional concentration of inspired CO2	Analysis of concentration of CO2 during inspiratory cycle.	Up to 12h
Other	Fractional concentration of inspired O2	Analysis of concentration of O2 in inspired gas.	Up to 12h
Other	Arterial blood oxygen saturation	Saturation of oxygen in arterial blood where measured by pulse oximetry and/or blood gas analysis.	Up to 12h
Other	Arterial blood CO2 partial pressure	Saturation of carbon dioxide in arterial blood measured by a blood gas analyzer.	Up to 12h
Other	pH measurement	pH of the condensed water in the drain valve and the PAL filter.	Single collected measurement not more than 60 min after extubation
Other	Length of surgery	Duration of surgical procedure.	Up to 12h
Other	Ventilation frequency	Measurement of patient breathing rate.	Up to 12h
Other	Ventilation pressure	Measurement of patient inspiratory pressure.	Up to 12h
Other	Tidal volume	Measurement of total lung volume as represented by the volume of air displaced between normal inhalation and exhalation.	Up to 12h
Other	Patient temperature	Body temperature of patient.	Up to 12h
Other	Relaxation status	Neuromuscular relaxation of patient.	Up to 12h
Other	Heart rate	Measurement and collection of patient heart rate.	Up to 12h
Other	Blood pressure	Measurement and collection of patient mean, systolic and diastolic blood pressure.	Up to 12h
Other	Patient weight	Weight of patient as collected from anaesthesia patient record database.	during preoperative assessment
Other	Patient height	Height of patient as collected from anaesthesia patient record database.	during preoperative assessment
Other	Patient age	Age of patient as collected from anaesthesia patient record database.	during preoperative assessment
Other	Patient medications	Medications being taken by patient as collected from anaesthesia patient record database.	during preoperative assessment
Other	Lung disease	Incidence of lung disease as collected from anaesthesia patient record database.	during preoperative assessment
Other	Anaesthetic agent	Inhaled and exhaled fraction of anaesthetic agent as collected from the anaesthetic patient record database	Up to 12h
Primary	End Tidal CO2	Concentration of carbon dioxide during expiratory cycle.	Up to 12h