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

Not Applicable

• Conditions: Alcohol Intoxication
• Interventions: Device: ClearMateTM

• Registration Number: NCT04229732
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-01-13
• Last Update Submitted: 2020-01-13
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-18
• Study Start: 2020-07
• Primary Completion: 2022-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• intoxicated requiring admission to an emergency unit

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Exclusion Criteria

• Liver or renal disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Alcohol elimination time constant	6-24 hours	From the recorded venous ethanol blood alcohol values, an elimination time constant will be calculated