Neuropsychiatric Sequelae of Carbon Monoxide PoisoningNCT00596180
Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Carbon Monoxide Poisoning
An observational study of Neuropsychiatric Sequelae of Carbon Monoxide Poisoning, run by Paul G. Harch, M.D. at 1 site in United States.
Trial summary
That SPECT brain imaging tracks and is consistent with clinical history and physical exam as well as cognitive testing. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuropsychiatric Sequelae of Carbon Monoxide Poisoning
- What is being tested?
- HBOT
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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
Who may be able to join
- Adults and children with non-acute carbon monoxide poisoning who underwent SPECT brain imaging as part of their evaluation and treatment
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Family Physicians Center
Marrero, Louisiana, 70072
Paul G Harch, M.D., 504-309-4948, paulharchmd@gmail.com
Paul G Harch, M.D.
About this study
That SPECT brain imaging tracks and is consistent with clinical history and physical exam as well as cognitive testing.
Read the 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.
- Being tested
- HBOT
- Keywords
- carbon monoxide poisoning, brain injury
- Medical subject headings
- Carbon Monoxide Poisoning, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBOTDrug
total body exposure to greater than atmospheric pressure oxygen
| Study group | Role | What they receive |
|---|---|---|
| 1 | HBOT Receives: Drug: HBOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPECT brain imaging
Measured: after completion of HBOT
Secondary outcomes (2)
clinical history and physical exam
Measured: after completion of HBOT
Neuropsychological testing
Neuropsychological testing performed after the final HBOT in those who had neuropsychological testing before HBOT
Measured: After the final HBOT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropsychiatric Sequelae of Carbon Monoxide PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul G. Harch, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Harch Hyperbaric Research Foundation
- Responsible party
- Sponsor-investigator, Paul G. Harch, M.D., Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Paul G Harch, M.D., Principal investigator, LSU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596180
- Sponsor's protocol ID
- LSU IRB #6626
- Status last verified
- Apr 2017
- First submitted
- 4 Jan 2008
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Carbon Monoxide Poisoning
- ClinicalTrials.gov ID
- NCT00596180
- Acronym / sponsor ID
- LSU IRB #6626
- Keywords
- carbon monoxide poisoning, brain injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Paul G. Harch, M.D.University, hospital or other
- Collaborators
- Harch Hyperbaric Research Foundation
- Study start
- Jan 2007
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: HBOTHBOT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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
Key inclusion criteria (1 listed)
- Adults and children with non-acute carbon monoxide poisoning who underwent SPECT brain imaging as part of their evaluation and treatment
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBOTtotal body exposure to greater than atmospheric pressure oxygen | Drug | 1 |
Primary outcome
SPECT brain imaging
Time frame: after completion of HBOT
2 secondary outcomes
clinical history and physical exam
Time frame: after completion of HBOT
Neuropsychological testing
Time frame: After the final HBOT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul G Harch, M.D. principal investigator
LSU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropsychiatric Sequelae of Carbon Monoxide Poisoning, run by Paul G. Harch, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul G Harch, M.D. (504-309-4948, paulharchmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPECT brain imaging (time frame: after completion of HBOT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017; AzTrials last refreshed its copy on 6 Nov 2026.