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

University Health Network, Toronto

Status: Unknown

Conditions: Alcohol Intoxication

Treatments: Device: ClearMateTM

Study type: Interventional

Funder types: Other

Identifiers

NCT04229732

CAPCR ID 15-8982.4

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• intoxicated requiring admission to an emergency unit

Exclusion criteria

• Liver or renal disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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40 participants in 2 patient groups

ClearMate Intervention

Experimental group

Description:

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

Treatment:

Device: ClearMateTM

Supportive Management

No Intervention group

Description:

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