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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 11, 2014
First Posted Date  ICMJE July 21, 2014
Last Update Posted Date October 13, 2016
Study Start Date  ICMJE August 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2014)
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%.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A New and Innovative Method for CO2 Removal in Anesthetic Circuits: Replacing Chemical Granulate
Official Title  ICMJE A New and Innovative Method for CO2 Removal in Anesthetic Circuits: Replacing Chemical Granulate
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE
  • End Tidal CO2
  • CO2 Removal
Intervention  ICMJE Device: memsorb
Study Arms  ICMJE
  • 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.
    Intervention: Device: memsorb
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02195245
Other Study ID Numbers  ICMJE DMF-CLIN-14-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party DMF Medical Incorporated
Study Sponsor  ICMJE DMF Medical Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account DMF Medical Incorporated
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP