- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00592891
Oxygen Toxicity of HBOT in Chronic Brain Injury
January 1, 2015 updated by: Paul G. Harch, M.D.
Oxygen Toxicity Effects Using Los-Pressure Hyperbaric Oxygen Therapy in the Treatment of Chronic Brain Injury
Hypothesis: That HBOT can be toxic in the low-pressure range.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
45
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Paul G Harch, M.D.
- Phone Number: 504-309-4948
- Email: paulharchmd@gmail.com
Study Locations
-
-
Louisiana
-
Marrero, Louisiana, United States, 70072
- Recruiting
- Family Physicians Center
-
Contact:
- Paul G Harch, M.D.
- Phone Number: 504-309-4948
- Email: paulharchmd@gmail.com
-
Principal Investigator:
- Paul G Harch, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Cerebral disorder of greater than one year's duration
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hyperbaric oxygen therapy
Patients undergoing low pressure HBOT for chronic brain injury
|
Total body pressurized oxygen
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Oxygen toxicity
Time Frame: After completion of hyperbaric oxygen therapy
|
After completion of hyperbaric oxygen therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul G Harch, M.D., LSU School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2002
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
January 2, 2008
First Submitted That Met QC Criteria
January 2, 2008
First Posted (Estimate)
January 14, 2008
Study Record Updates
Last Update Posted (Estimate)
January 5, 2015
Last Update Submitted That Met QC Criteria
January 1, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LSU IRB #5209
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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