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

Not Applicable

Completed

• Conditions: CO2 Removal; End Tidal CO2
• Interventions: Device: memsorb

• Registration Number: NCT02195245
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-17
• Study First Posted: 2014-07-21
• Study Start: 2014-08
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
memsorb	memsorb	New CO2 filter - data is collected using the new CO2 absorber.

Primary Outcome Measures

Name	Time	Method
End tidal CO2 level	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%.

Trial Locations

Locations (1)

Queen Elizabeth II HSC, Halifax Infirmary Site; 🇨🇦 Halifax, Nova Scotia, Canada