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

CO2 Removal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02195245
• Other study ID #: DMF-CLIN-14-01
• Status: Completed
• Phase: N/A
• First received: July 11, 2014
• Last updated: October 12, 2016
• Start date: August 2014
• Est. completion date: October 2014

Study information

• Verified date: October 2016
• Source: DMF Medical Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• CO2 Removal
• End Tidal CO2

Intervention

Device:
• memsorb

Locations

Country	Name	City	State
Canada	Queen Elizabeth II HSC, Halifax Infirmary Site	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
DMF Medical Incorporated

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No