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

Sponsor
University Health Network, Toronto (Other)
Overall Status
Unknown status
CT.gov ID
NCT04229732
Collaborator
Thornhill Medical (Other)
40
Enrollment
2
Arms
24
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: ClearMateTM
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Trials of Ventilation Assisted Substance Elimination Via the Lung - Ethanol (VASEL - Ethanol)
Anticipated Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: ClearMate Intervention

Participants undergo passive isocapnic hyperventilation via the ClearMateTM device and have regular venous blood samples obtained to measure ethanol clearance kinetics.

Device: ClearMateTM
Passive isocapnic hyperventilation breathing circuit.
No Intervention: Supportive Management

Participants receive standard of care, supportive management, for alcohol intoxication, having regular venous blood samples obtained to measure ethanol clearance kinetics.

Outcome Measures

Primary Outcome Measures

  1. Alcohol elimination time constant [6-24 hours]

    From the recorded venous ethanol blood alcohol values, an elimination time constant will be calculated

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • intoxicated requiring admission to an emergency unit
Exclusion Criteria:
  • Liver or renal disease

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Health Network, Toronto
  • Thornhill Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT04229732
Other Study ID Numbers:
  • CAPCR ID 15-8982.4
First Posted:
Jan 18, 2020
Last Update Posted:
Jan 18, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Alcoholic Intoxication

Study Results

No Results Posted as of Jan 18, 2020