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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

Tracking Information
First Submitted Date  ICMJE January 2, 2008
First Posted Date  ICMJE January 14, 2008
Last Update Posted Date January 5, 2015
Study Start Date  ICMJE April 2002
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2014)
Oxygen toxicity [ Time Frame: After completion of hyperbaric oxygen therapy ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 2, 2008)
Oxygen toxicity [ Time Frame: 17 years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxygen Toxicity of HBOT in Chronic Brain Injury
Official Title  ICMJE Oxygen Toxicity Effects Using Los-Pressure Hyperbaric Oxygen Therapy in the Treatment of Chronic Brain Injury
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adult and Pediatric Chronic Cerebral Disorders
Intervention  ICMJE Drug: Hyperbaric oxygen therapy
Total body pressurized oxygen
Study Arms  ICMJE Experimental: Hyperbaric oxygen therapy
Patients undergoing low pressure HBOT for chronic brain injury
Intervention: Drug: Hyperbaric oxygen therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 30, 2014)
45
Original Estimated Enrollment  ICMJE
 (submitted: January 2, 2008)
33
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Cerebral disorder of greater than one year's duration

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00592891
Other Study ID Numbers  ICMJE LSU IRB #5209
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paul G. Harch, M.D., Louisiana State University Health Sciences Center in New Orleans
Study Sponsor  ICMJE Paul G. Harch, M.D.
Collaborators  ICMJE Harch Hyperbaric Research Foundation
Investigators  ICMJE
Principal Investigator: Paul G Harch, M.D. LSU School of Medicine
PRS Account Louisiana State University Health Sciences Center in New Orleans
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP