Alcohol IntoxicationNCT04229732
Trials of Ventilation Assisted Substance Elimination Via the Lung - Ethanol (VASEL - Ethanol)
A study testing ClearMateTM in people with Alcohol Intoxication, run by University Health Network, Toronto.
Trial summary
This prospective, randomized control trial will use passive, isocapnic hyperventilation, applied via the ClearMateTM device (Thornhill Medical, Inc) versus controls receiving standard of care supportive management for severe alcohol intoxication to assess for enhanced ethanol elimination kinetics. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Intoxication
- What is being tested?
- ClearMateTM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to Jul 2022
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- intoxicated requiring admission to an emergency unit
Who cannot join
- Liver or renal disease
About this study
This prospective, randomized control trial will use passive, isocapnic hyperventilation, applied via the ClearMateTM device (Thornhill Medical, Inc) versus controls receiving standard of care supportive management for severe alcohol intoxication to assess for enhanced ethanol elimination kinetics.
- Conditions
- Alcohol Intoxication
- Being tested
- ClearMateTM
- Medical subject headings
- Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClearMateTMDevice
Passive isocapnic hyperventilation breathing circuit.
| Study group | Role | What they receive |
|---|---|---|
| ClearMate Intervention | Experimental | Participants undergo passive isocapnic hyperventilation via the ClearMateTM device and have regular venous blood samples obtained to measure ethanol clearance kinetics. Receives: Device: ClearMateTM |
| Supportive Management | No intervention | Participants receive standard of care, supportive management, for alcohol intoxication, having regular venous blood samples obtained to measure ethanol clearance kinetics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol elimination time constant
From the recorded venous ethanol blood alcohol values, an elimination time constant will be calculated
Measured: 6-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study startJul 2020 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol IntoxicationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Thornhill Medical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229732
- Sponsor's protocol ID
- CAPCR ID 15-8982.4
- Status last verified
- Jan 2020
- First submitted
- 13 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trials of Ventilation Assisted Substance Elimination Via the Lung - Ethanol (VASEL - Ethanol)
- ClinicalTrials.gov ID
- NCT04229732
- Acronym / sponsor ID
- CAPCR ID 15-8982.4
- Conditions
- Alcohol Intoxication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Thornhill Medical
- Study start
- Jul 2020 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 18 Jan 2020 (actual)
- 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.
This prospective, randomized control trial will use passive, isocapnic hyperventilation, applied via the ClearMateTM device (Thornhill Medical, Inc) versus controls receiving standard of care supportive management for severe alcohol intoxication to assess for enhanced ethanol elimination kinetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ClearMate Intervention | Experimental | Device: ClearMateTMParticipants undergo passive isocapnic hyperventilation via the ClearMateTM device and have regular venous blood samples obtained to measure ethanol clearance kinetics. |
| Supportive Management | No intervention | –Participants receive standard of care, supportive management, for alcohol intoxication, having regular venous blood samples obtained to measure ethanol clearance kinetics. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- intoxicated requiring admission to an emergency unit
Key exclusion criteria (1 listed)
- Liver or renal disease
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 |
|---|---|---|
| ClearMateTMPassive isocapnic hyperventilation breathing circuit. | Device | ClearMate Intervention |
Primary outcome
Alcohol elimination time constant
Time frame: 6-24 hours
From the recorded venous ethanol blood alcohol values, an elimination time constant will be calculated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing ClearMateTM in people with Alcohol Intoxication, run by University Health Network, Toronto.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Alcohol elimination time constant (time frame: 6-24 hours). 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 18 Jan 2020.