Oxygen Toxicity of HBOT in Chronic Brain Injury | NCT00592891

Studies
Oxygen Toxicity of HBOT in Chronic Brain Injury

NCT00592891

Sponsor

Paul G. Harch, M.D.

Status

Unknown status

Last Update Posted

Jan 5, 2015Estimated

Enrollment

45Estimated

Phase

Phase 1

Conditions

Adult and Pediatric Chronic Cerebral Disorders

Interventions

Hyperbaric oxygen therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2002

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Jan 2, 2008

First Submission Date that Met QC Criteria

Jan 2, 2008

First Posted Date

Jan 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 1, 2015

Last Update Posted Date

Jan 5, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Paul G. Harch, M.D., Clinical Professor of Medicine, Louisiana State University Health Sciences Center in New OrleansSponsor-Investigator

Lead Sponsor

Paul G. Harch, M.D.OTHER

Collaborators

Name	Class
Harch Hyperbaric Research Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hyperbaric oxygen therapy	Experimental	Patients undergoing low pressure HBOT for chronic brain injury	Drug: Hyperbaric oxygen therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyperbaric oxygen therapy	Drug	Total body pressurized oxygen	Hyperbaric oxygen therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oxygen toxicity		After completion of hyperbaric oxygen therapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cerebral disorder of greater than one year's duration

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Paul G Harch, M.D.	Contact	504-309-4948		paulharchmd@gmail.com

Overall Officials

Name	Affiliation	Role
Paul G Harch, M.D.	LSU School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Family Physicians Center	Recruiting	Marrero	Louisiana	70072	United States

Condition Browse Module

MeSH Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases

Ancestor Terms

ID	Term
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006931	Hyperbaric Oxygenation

Ancestor Terms

ID	Term
D010102	Oxygen Inhalation Therapy
D012138	Respiratory Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided