Oxygen Toxicity Effects Using Los-Pressure Hyperbaric Oxygen Therapy in the Treatment of Chronic Brain Injury
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Oxygen toxicity
Study Overview
Brief Summary
Hypothesis: That HBOT can be toxic in the low-pressure range.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Cerebral disorder of greater than one year's duration
Exclusion Criteria
- Not provided
Arms & Interventions
Hyperbaric oxygen therapy
Patients undergoing low pressure HBOT for chronic brain injury
Intervention: Hyperbaric oxygen therapy (Drug)
Outcomes
Primary Outcomes
Oxygen toxicity
Time Frame: After completion of hyperbaric oxygen therapy
Secondary Outcomes
No secondary outcomes reported
Investigators
Paul G. Harch, M.D.
Clinical Professor of Medicine
Louisiana State University Health Sciences Center in New Orleans