Clinical trial NCT03014336: A New and Innovative Method for CO2 Removal in Anesthetic Circuits: Replacing Chemical Granulate
Official title: A New and Innovative Method for CO2 Removal in Anesthetic Circuits:
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Keywords: co2 removal, anesthesia
Lead sponsor: DMF Medical Incorporated
Sponsor class: INDUSTRY
First posted: 2017-01-09
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: End Tidal CO2
timeFrame: Up to 12h
Secondary outcomes:
Other outcomes:
measure: Fresh gas flow
timeFrame: Up to 12h
measure: Fractional concentration of inspired CO2
timeFrame: Up to 12h
measure: Fractional concentration of inspired O2
timeFrame: Up to 12h
measure: Arterial blood oxygen saturation
timeFrame: Up to 12h
measure: Arterial blood CO2 partial pressure
timeFrame: Up to 12h
measure: pH measurement
timeFrame: Single collected measurement not more than 60 min after extubation
measure: Length of surgery
timeFrame: Up to 12h
measure: Ventilation frequency
timeFrame: Up to 12h
measure: Ventilation pressure
timeFrame: Up to 12h
measure: Tidal volume
timeFrame: Up to 12h
measure: Patient temperature
timeFrame: Up to 12h
measure: Relaxation status
timeFrame: Up to 12h
measure: Heart rate
timeFrame: Up to 12h
measure: Blood pressure
timeFrame: Up to 12h
measure: Patient weight
timeFrame: during preoperative assessment
measure: Patient height
timeFrame: during preoperative assessment
measure: Patient age
timeFrame: during preoperative assessment
measure: Patient medications
timeFrame: during preoperative assessment
measure: Lung disease
timeFrame: during preoperative assessment
measure: Anaesthetic agent
timeFrame: Up to 12h
Locations:
city: Halifax
country: Canada
facility: Queen Elizabeth II HSC, Halifax Infirmary Site
state: Nova Scotia
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: Nova Scotia Health Authority
name: Orlando Hung, MD
role: PRINCIPAL_INVESTIGATOR
References: