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NCT04229732 Clinical Trial

Trials of Ventilation Assisted Substance Elimination Via the Lung - Ethanol (VASEL - Ethanol)

Alcohol Intoxication Clinical Trial

Official title:
Trials of Ventilation Assisted Substance Elimination Via the Lung - Ethanol (VASEL - Ethanol)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04229732
Other study ID # CAPCR ID 15-8982.4
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2020
Est. completion date July 2022

Study information
Verified date January 2020
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date July 2022
Est. primary completion date July 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- intoxicated requiring admission to an emergency unit

Exclusion Criteria:

- Liver or renal disease

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ClearMateTM
Passive isocapnic hyperventilation breathing circuit.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University Health Network, Toronto Thornhill Medical

Outcome
Type Measure Description Time frame Safety issue
Primary Alcohol elimination time constant From the recorded venous ethanol blood alcohol values, an elimination time constant will be calculated 6-24 hours
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