Oxygen Toxicity of HBOT in Chronic Brain Injury

Paul G. Harch, M.D.

Status and phase: Unknown; Phase 1

Conditions: Adult and Pediatric Chronic Cerebral Disorders

Treatments: Drug: Hyperbaric oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00592891

LSU IRB #5209

Details and patient eligibility

About

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

Full description

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.

Enrollment: 45 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cerebral disorder of greater than one year's duration

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Hyperbaric oxygen therapy

Experimental group

Description:

Patients undergoing low pressure HBOT for chronic brain injury

Treatment:

Drug: Hyperbaric oxygen therapy