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Oxygen Toxicity of HBOT in Chronic Brain Injury

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Louisiana State University Health Sciences Center in New Orleans.
Recruitment status was:  Recruiting
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: January 1, 2015
Last verified: January 2015
  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: 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 ]

Estimated Enrollment: 45
Study Start Date: April 2002
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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

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:

  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

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: January 1, 2015

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
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Damage, Chronic

ClinicalTrials.gov processed this record on March 27, 2017