- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03014336
A New and Innovative Method for CO2 Removal in Anesthetic Circuits: Replacing Chemical Granulate (memsorb)
A New and Innovative Method for CO2 Removal in Anesthetic Circuits:
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Katy Scurman
- Phone Number: (902) 221-0451
- Email: schurman@dmfmedical.com
Study Contact Backup
- Name: Vera Lloyd
- Phone Number: (902) 225-3893
- Email: lloyd@dmfmedical.com
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 3A7
- Recruiting
- Queen Elizabeth II HSC, Halifax Infirmary Site
-
Contact:
- Orlando Hung, MD
- Phone Number: (902)473-7736
- Email: orlando.hung@dal.ca
-
Principal Investigator:
- Orlando Hung, MD
-
-
Quebec
-
Montréal, Quebec, Canada, H4A 3J1
- Completed
- McGill University Health Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Patients receive standard care with a standard CO2 absorber and agree to include their data in the study.
|
|
Experimental: memsorb
Patients agree to receive standard care but using memsorb, the new CO2 filter evaluated in this study.
|
memsorb is a CO2 filter replacing current chemical CO2 absorbers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
End Tidal CO2
Time Frame: Up to 12h
|
Concentration of carbon dioxide during expiratory cycle.
|
Up to 12h
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fresh gas flow
Time Frame: Up to 12h
|
Analysis of fresh gas flow into the machine.
|
Up to 12h
|
Fractional concentration of inspired CO2
Time Frame: Up to 12h
|
Analysis of concentration of CO2 during inspiratory cycle.
|
Up to 12h
|
Fractional concentration of inspired O2
Time Frame: Up to 12h
|
Analysis of concentration of O2 in inspired gas.
|
Up to 12h
|
Arterial blood oxygen saturation
Time Frame: Up to 12h
|
Saturation of oxygen in arterial blood where measured by pulse oximetry and/or blood gas analysis.
|
Up to 12h
|
Arterial blood CO2 partial pressure
Time Frame: Up to 12h
|
Saturation of carbon dioxide in arterial blood measured by a blood gas analyzer.
|
Up to 12h
|
pH measurement
Time Frame: Single collected measurement not more than 60 min after extubation
|
pH of the condensed water in the drain valve and the PAL filter.
|
Single collected measurement not more than 60 min after extubation
|
Length of surgery
Time Frame: Up to 12h
|
Duration of surgical procedure.
|
Up to 12h
|
Ventilation frequency
Time Frame: Up to 12h
|
Measurement of patient breathing rate.
|
Up to 12h
|
Ventilation pressure
Time Frame: Up to 12h
|
Measurement of patient inspiratory pressure.
|
Up to 12h
|
Tidal volume
Time Frame: Up to 12h
|
Measurement of total lung volume as represented by the volume of air displaced between normal inhalation and exhalation.
|
Up to 12h
|
Patient temperature
Time Frame: Up to 12h
|
Body temperature of patient.
|
Up to 12h
|
Relaxation status
Time Frame: Up to 12h
|
Neuromuscular relaxation of patient.
|
Up to 12h
|
Heart rate
Time Frame: Up to 12h
|
Measurement and collection of patient heart rate.
|
Up to 12h
|
Blood pressure
Time Frame: Up to 12h
|
Measurement and collection of patient mean, systolic and diastolic blood pressure.
|
Up to 12h
|
Patient weight
Time Frame: during preoperative assessment
|
Weight of patient as collected from anaesthesia patient record database.
|
during preoperative assessment
|
Patient height
Time Frame: during preoperative assessment
|
Height of patient as collected from anaesthesia patient record database.
|
during preoperative assessment
|
Patient age
Time Frame: during preoperative assessment
|
Age of patient as collected from anaesthesia patient record database.
|
during preoperative assessment
|
Patient medications
Time Frame: during preoperative assessment
|
Medications being taken by patient as collected from anaesthesia patient record database.
|
during preoperative assessment
|
Lung disease
Time Frame: during preoperative assessment
|
Incidence of lung disease as collected from anaesthesia patient record database.
|
during preoperative assessment
|
Anaesthetic agent
Time Frame: Up to 12h
|
Inhaled and exhaled fraction of anaesthetic agent as collected from the anaesthetic patient record database
|
Up to 12h
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Orlando Hung, MD, Nova Scotia Health Authority
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DMF-CLIN-16-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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