Trials of Ventilation Assisted Substance Elimination Via the Lung - Ethanol (VASEL - Ethanol)
Primary Purpose
Alcohol Intoxication
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ClearMateTM
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Intoxication
Eligibility Criteria
Inclusion Criteria:
- intoxicated requiring admission to an emergency unit
Exclusion Criteria:
- Liver or renal disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ClearMate Intervention
Supportive Management
Arm Description
Participants undergo passive isocapnic hyperventilation via the ClearMateTM device and have regular venous blood samples obtained to measure ethanol clearance kinetics.
Participants receive standard of care, supportive management, for alcohol intoxication, having regular venous blood samples obtained to measure ethanol clearance kinetics.
Outcomes
Primary Outcome Measures
Alcohol elimination time constant
From the recorded venous ethanol blood alcohol values, an elimination time constant will be calculated
Secondary Outcome Measures
Full Information
NCT ID
NCT04229732
First Posted
January 13, 2020
Last Updated
January 13, 2020
Sponsor
University Health Network, Toronto
Collaborators
Thornhill Medical
1. Study Identification
Unique Protocol Identification Number
NCT04229732
Brief Title
Trials of Ventilation Assisted Substance Elimination Via the Lung - Ethanol (VASEL - Ethanol)
Official Title
Trials of Ventilation Assisted Substance Elimination Via the Lung - Ethanol (VASEL - Ethanol)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2020 (Anticipated)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Thornhill Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Intoxication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ClearMate Intervention
Arm Type
Experimental
Arm Description
Participants undergo passive isocapnic hyperventilation via the ClearMateTM device and have regular venous blood samples obtained to measure ethanol clearance kinetics.
Arm Title
Supportive Management
Arm Type
No Intervention
Arm Description
Participants receive standard of care, supportive management, for alcohol intoxication, having regular venous blood samples obtained to measure ethanol clearance kinetics.
Intervention Type
Device
Intervention Name(s)
ClearMateTM
Intervention Description
Passive isocapnic hyperventilation breathing circuit.
Primary Outcome Measure Information:
Title
Alcohol elimination time constant
Description
From the recorded venous ethanol blood alcohol values, an elimination time constant will be calculated
Time Frame
6-24 hours
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Genders will be noted and used for separate analysis due to known gender differences in alcohol elimination kinetics.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
intoxicated requiring admission to an emergency unit
Exclusion Criteria:
Liver or renal disease
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Trials of Ventilation Assisted Substance Elimination Via the Lung - Ethanol (VASEL - Ethanol)
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