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

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.

Study Overview

• Status: Completed
• Conditions: CO2 Removal; End Tidal CO2
• Intervention / Treatment: Device: memsorb

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
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Queen Elizabeth II HSC, Halifax Infirmary Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End tidal CO2 level	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%.	Continuous (5min intervals) over duration of anesthesia. No data collection prior or post anesthesia.

Collaborators and Investigators

• Sponsor: DMF Medical Incorporated

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: July 11, 2014
• First Submitted That Met QC Criteria: July 17, 2014
• First Posted (Estimate): July 21, 2014

Study Record Updates

• Last Update Posted (Estimate): October 13, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: anesthesia; device; CO2 filter
• Other Study ID Numbers: DMF-CLIN-14-01