Oxygen Toxicity of HBOT in Chronic Brain Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Louisiana State University Health Sciences Center in New Orleans
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
ClinicalTrials.gov Identifier:
NCT00592891
First received: January 2, 2008
Last updated: March 30, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Adult and Pediatric Chronic Cerebral Disorders
Drug: Hyperbaric oxygen therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oxygen Toxicity Effects Using Los-Pressure Hyperbaric Oxygen Therapy in the Treatment of Chronic Brain Injury

Resource links provided by NLM:


Further study details as provided by Louisiana State University Health Sciences Center in New Orleans:

Primary Outcome Measures:
  • Oxygen toxicity [ Time Frame: After completion of hyperbaric oxygen therapy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: April 2002
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyperbaric oxygen therapy
Patients undergoing low pressure HBOT for chronic brain injury
Drug: Hyperbaric oxygen therapy
Total body pressurized oxygen

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cerebral disorder of greater than one year's duration

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: January 2, 2008
Last Updated: March 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Louisiana State University Health Sciences Center in New Orleans:
brain injury
brain disorders

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

ClinicalTrials.gov processed this record on August 21, 2014