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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04229732

Enrollment

Registered

2020-01-18

Start date

2020-07-31

Completion date

2022-07-31

Last updated

2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Intoxication

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.

Interventions

DEVICEClearMateTM

Passive isocapnic hyperventilation breathing circuit.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* intoxicated requiring admission to an emergency unit

Exclusion criteria

* Liver or renal disease

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026