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Oxygen Toxicity of HBOT in Chronic Brain Injury

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ClinicalTrials.gov Identifier: NCT00592891
Recruitment Status : Unknown
Verified January 2015 by Paul G. Harch, M.D., Louisiana State University Health Sciences Center in New Orleans.
Recruitment status was:  Recruiting
First Posted : January 14, 2008
Last Update Posted : January 5, 2015
Sponsor:
Collaborator:
Harch Hyperbaric Research Foundation
Information provided by (Responsible Party):
Paul G. Harch, M.D., Louisiana State University Health Sciences Center in New Orleans

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

Condition or disease Intervention/treatment Phase
Adult and Pediatric Chronic Cerebral Disorders Drug: Hyperbaric oxygen therapy Phase 1

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  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oxygen Toxicity Effects Using Los-Pressure Hyperbaric Oxygen Therapy in the Treatment of Chronic Brain Injury
Study Start Date : April 2002
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Hyperbaric oxygen therapy
Patients undergoing low pressure HBOT for chronic brain injury
Drug: Hyperbaric oxygen therapy
Total body pressurized oxygen



Primary Outcome Measures :
  1. Oxygen toxicity [ Time Frame: After completion of hyperbaric oxygen therapy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cerebral disorder of greater than one year's duration

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592891


Contacts
Contact: Paul G Harch, M.D. 504-309-4948 paulharchmd@gmail.com

Locations
United States, Louisiana
Family Physicians Center Recruiting
Marrero, Louisiana, United States, 70072
Contact: Paul G Harch, M.D.    504-309-4948    paulharchmd@gmail.com   
Principal Investigator: Paul G Harch, M.D.         
Sponsors and Collaborators
Paul G. Harch, M.D.
Harch Hyperbaric Research Foundation
Investigators
Principal Investigator: Paul G Harch, M.D. LSU School of Medicine

Responsible Party: Paul G. Harch, M.D., Clinical Professor of Medicine, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT00592891     History of Changes
Other Study ID Numbers: LSU IRB #5209
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: January 5, 2015
Last Verified: January 2015

Keywords provided by Paul G. Harch, M.D., Louisiana State University Health Sciences Center in New Orleans:
brain injury
brain disorders

Additional relevant MeSH terms:
Brain Injuries
Brain Injury, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Damage, Chronic