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

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ClinicalTrials.gov Identifier: NCT02195245
Recruitment Status : Completed
First Posted : July 21, 2014
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
DMF Medical Incorporated

Brief Summary:
CO2 removal is a mandatory part of modern anesthesia systems. Current chemical absorbers pose problems as the chemical granulate reacts not only with the CO2 but also the anesthetic drugs, producing organ toxic substances. The proposed CO2 absorber provides a solution to the problem of organ-toxin production in anesthetic circuits.

Condition or disease Intervention/treatment Phase
End Tidal CO2 CO2 Removal Device: memsorb Not Applicable

Detailed Description:

CO2 removal is a mandatory part of modern anesthesia systems. Current chemical absorbers pose problems as the chemical granulate reacts not only with the CO2 but also the anesthetic drugs, producing organ toxic substances. The proposed CO2 absorber provides a solution to the problem of organ-toxin production in anesthetic circuits.

This new absorber can be easily integrated into any anesthesia circuit, and can effectively remove CO2 without reacting with anesthetic drugs, thus eliminating organ-toxic by-products.

It uses advanced membrane technology to separate gas flows within the circuit, separating the expensive anesthetic vapors from the CO2 (the main by-product of metabolism). Anesthetic vapors thus remain in the closed loop circuit, while CO2 is separated and exhausted to the atmosphere, rather than being absorbed through a chemical reaction.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A New and Innovative Method for CO2 Removal in Anesthetic Circuits: Replacing Chemical Granulate
Study Start Date : August 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Arm Intervention/treatment
No Intervention: Control
Control - Observational (non interventional) data is collected from current state of the art absorber devices.
Experimental: memsorb
New CO2 filter - data is collected using the new CO2 absorber.
Device: memsorb



Primary Outcome Measures :
  1. End tidal CO2 level [ Time Frame: Continuous (5min intervals) over duration of anesthesia. No data collection prior or post anesthesia. ]

    After completion of the surgery, the digital respiration records are exported from the hospital database.

    End tidal CO2 is assessed as either in range [4.1-5.6]% or out of range <4.1% or >5.6%.




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiology Physical Status Class I, II, III (low-medium risk patient)
  • English-speaking patients
  • Scheduled for elective surgery
  • Length of anesthesia ≥ 60 minutes

Exclusion Criteria:

  • Pregnant
  • American Society of Anesthesiology Physical Status Class IV (high risk patient)
  • Patients schedule for emergency surgery
  • Known respiratory disease, including COPD and severe asthma
  • Have elevated pressure in your brain (intra cranial pressure, ICP)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02195245


Locations
Canada, Nova Scotia
Queen Elizabeth II HSC, Halifax Infirmary Site
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
DMF Medical Incorporated

Responsible Party: DMF Medical Incorporated
ClinicalTrials.gov Identifier: NCT02195245     History of Changes
Other Study ID Numbers: DMF-CLIN-14-01
First Posted: July 21, 2014    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016

Keywords provided by DMF Medical Incorporated:
CO2 filter
anesthesia
device

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs