Oxygen Toxicity of HBOT in Chronic Brain Injury

Adult and Pediatric Chronic Cerebral Disorders Clinical Trial

Official title:

Oxygen Toxicity Effects Using Los-Pressure Hyperbaric Oxygen Therapy in the Treatment of Chronic Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00592891
• Other study ID #: LSU IRB #5209
• Status: Recruiting
• Phase: Phase 1
• First received: January 2, 2008
• Last updated: January 1, 2015
• Start date: April 2002
• Est. completion date: December 2016

Study information

• Verified date: January 2015
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: Paul G Harch, M.D.
• Phone: 504-309-4948
• Email: paulharchmd[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Cerebral disorder of greater than one year's duration

Exclusion Criteria:

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult and Pediatric Chronic Cerebral Disorders
• Brain Injuries
• Brain Injury, Chronic

Intervention

Drug:
• Hyperbaric oxygen therapy
Total body pressurized oxygen

Locations

Country	Name	City	State
United States	Family Physicians Center	Marrero	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Paul G. Harch, M.D.	Harch Hyperbaric Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen toxicity		After completion of hyperbaric oxygen therapy	Yes