Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Carb... | NCT00596180

Studies
Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Carbon Monoxide Poisoning

NCT00596180

Sponsor

Paul G. Harch, M.D.

Status

Unknown status

Last Update Posted

Apr 18, 2017Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Neuropsychiatric Sequelae of Carbon Monoxide Poisoning

Interventions

HBOT

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

Apr 2017

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

Jan 2007

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Jan 4, 2008

First Submission Date that Met QC Criteria

Jan 4, 2008

First Posted Date

Jan 16, 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

Apr 16, 2017

Last Update Posted Date

Apr 18, 2017Actual

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

That SPECT brain imaging tracks and is consistent with clinical history and physical exam as well as cognitive testing.

Detailed Description

The study is a retrospective review of the PI's experience using SPECT brain imaging and hyperbaric oxygen therapy in the diagnosis and treatment of non-acute phases of carbon monoxide poisoning. The purpose is to see if the SPECT brain imaging is consistent with the clinical condition and cognitive testing on the patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		HBOT	Drug: HBOT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HBOT	Drug	total body exposure to greater than atmospheric pressure oxygen	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SPECT brain imaging		after completion of HBOT

Secondary Outcomes

Measure	Description	Time Frame
clinical history and physical exam		after completion of HBOT
Neuropsychological testing	Neuropsychological testing performed after the final HBOT in those who had neuropsychological testing before HBOT

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults and children with non-acute carbon monoxide poisoning who underwent SPECT brain imaging as part of their evaluation and treatment

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

Adults and children with non-acute carbon monoxide poisoning who underwent SPECT brain imaging as part of their evaluation and treatment. Retrospective chart review

Sampling Method

Non-Probability Sample

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002249	Carbon Monoxide Poisoning
D001930	Brain Injuries

Ancestor Terms

ID	Term
D005739	Gas Poisoning
D011041	Poisoning
D064419	Chemically-Induced Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided