Oxygen Toxicity of HBOT in Chronic Brain Injury

NCT ID: NCT00592891

Last Updated: 2015-01-05

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

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2016-12-31

Brief Summary

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Hypothesis: That HBOT can be toxic in the low-pressure range.

Detailed Description

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The study is a retrospective review of the author's experience treating chronic brain injury with HBOT, supplemented by cases communicated to the author, who developed untoward effects during or after their HBOT. The object of the study was to affirm or refute the author's general impression that there was an optimal dose of HBOT in chronic brain injury which was lower than the traditional dose applied in chronic non-central nervous system wounding. Furthermore, when this lower dosage range was exceeded and approached the traditional doses for non-CNS wounding oxygen toxicity would result. To address these impressions the study seeks to review the author's medical records and other patient/doctor communications to the author where side effects of HBOT occurred in the treatment of chronic brain injury and abstract signs, symptoms, and the dose of HBOT employed.

Conditions

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Adult and Pediatric Chronic Cerebral Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyperbaric oxygen therapy

Patients undergoing low pressure HBOT for chronic brain injury

Group Type EXPERIMENTAL

Hyperbaric oxygen therapy

Intervention Type DRUG

Total body pressurized oxygen

Interventions

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Hyperbaric oxygen therapy

Total body pressurized oxygen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Cerebral disorder of greater than one year's duration

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harch Hyperbaric Research Foundation

OTHER

Sponsor Role collaborator

Paul G. Harch, M.D.

OTHER

Sponsor Role lead

Responsible Party

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Paul G. Harch, M.D.

Clinical Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Paul G Harch, M.D.

Role: PRINCIPAL_INVESTIGATOR

LSU School of Medicine

Locations

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Family Physicians Center

Marrero, Louisiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Paul G Harch, M.D.

Role: CONTACT

504-309-4948

Facility Contacts

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Paul G Harch, M.D.

Role: primary

504-309-4948

Other Identifiers

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LSU IRB #5209

Identifier Type: -

Identifier Source: org_study_id

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