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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
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Intoxication

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 13, 2020
    Last Updated
    January 13, 2020
    Sponsor
    University Health Network, Toronto
    Collaborators
    Thornhill Medical
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    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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