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

NCT ID: NCT04229732

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-31

Study Completion Date

2022-07-31

Brief Summary

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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

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Conditions

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Alcohol Intoxication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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ClearMate Intervention

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

Group Type EXPERIMENTAL

ClearMateTM

Intervention Type DEVICE

Passive isocapnic hyperventilation breathing circuit.

Supportive Management

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ClearMateTM

Passive isocapnic hyperventilation breathing circuit.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* intoxicated requiring admission to an emergency unit

Exclusion Criteria

* Liver or renal disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Thornhill Medical

UNKNOWN

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CAPCR ID 15-8982.4

Identifier Type: -

Identifier Source: org_study_id

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