End Tidal CO2NCT02195245
A New and Innovative Method for CO2 Removal in Anesthetic Circuits: Replacing Chemical Granulate
A study testing memsorb in people with End Tidal CO2 and CO2 Removal, run by DMF Medical Incorporated at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Tidal CO2, CO2 Removal
- What is being tested?
- memsorb
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Queen Elizabeth II HSC, Halifax Infirmary Site
Halifax, Nova Scotia, B3H 3A7
About this study
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.
Read the 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.
- Conditions
- End Tidal CO2, CO2 Removal
- Being tested
- memsorb
- Keywords
- CO2 filter, anesthesia, device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
memsorbDevice
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control - Observational (non interventional) data is collected from current state of the art absorber devices. |
| memsorb | Experimental | New CO2 filter - data is collected using the new CO2 absorber. Receives: Device: memsorb |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Continuous (5min intervals) over duration of anesthesia. No data collection prior or post anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Tidal CO2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- DMF Medical Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195245
- Sponsor's protocol ID
- DMF-CLIN-14-01
- Status last verified
- Oct 2016
- First submitted
- 11 Jul 2014
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New and Innovative Method for CO2 Removal in Anesthetic Circuits: Replacing Chemical Granulate
- ClinicalTrials.gov ID
- NCT02195245
- Acronym / sponsor ID
- DMF-CLIN-14-01
- Conditions
- End Tidal CO2, CO2 Removal
- Keywords
- CO2 filter, anesthesia, device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- DMF Medical IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 21 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control - Observational (non interventional) data is collected from current state of the art absorber devices. |
| memsorb | Experimental | Device: memsorbNew CO2 filter - data is collected using the new CO2 absorber. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| memsorb | Device | memsorb |
Primary outcome
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%.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing memsorb in people with End Tidal CO2 and CO2 Removal, run by DMF Medical Incorporated at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End tidal CO2 level (time frame: Continuous (5min intervals) over duration of anesthesia. No data collection prior or post anesthesia.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2016.