Brain TraumaNIRSNCT01556620
Is NIRS Able to Detect Ischemia Following Brain Insult
An observational study of Brain Trauma and SAH, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
We hypothesize that newly developped NIRS sensor (EQUANOX Advance™, 8004CA, NONIN Medical, USA)is able to detect ischemic events recorded by brain tissue oxygen probe (Licox, Integra Neurosciences, USA) and that values are correlated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Trauma, SAH, ICH
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Jan 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Brain injury (head trauma, SAH, ICH)
Who may be able to join
- Necessity of monitoring by PtiO2 and ICP
Who cannot join
- Inability to apply NIRS sensor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The New 4 Wavelengths EQUANOX NIRS Sensor: Correlation and Detection of Ischemic Episodes. An Observational Comparative Study Versus PtiO2
We hypothesize that newly developped NIRS sensor (EQUANOX Advance™, 8004CA, NONIN Medical, USA)is able to detect ischemic events recorded by brain tissue oxygen probe (Licox, Integra Neurosciences, USA) and that values are correlated.
- Conditions
- Brain Trauma, SAH, ICH
- Keywords
- PtiO2, NIRS
- Medical subject headings
- Brain Injuries, Traumatic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startNov 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TraumaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BORET Henry, Direction Centrale du Service de Santé des Armées
- Investigators
- Henry BORET, MD, Principal investigator, Direction Centrale du Service de Santé des Armées
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556620
- Sponsor's protocol ID
- DCSSA
- Acronym
- NIRS
- Status last verified
- Mar 2012
- First submitted
- 15 Mar 2012
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The New 4 Wavelengths EQUANOX NIRS Sensor: Correlation and Detection of Ischemic Episodes. An Observational Comparative Study Versus PtiO2
- ClinicalTrials.gov ID
- NCT01556620
- Acronym / sponsor ID
- NIRS / DCSSA
- Conditions
- Brain Trauma, SAH, ICH
- Keywords
- PtiO2, NIRS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 16 Mar 2012 (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.
We hypothesize that newly developped NIRS sensor (EQUANOX Advance™, 8004CA, NONIN Medical, USA)is able to detect ischemic events recorded by brain tissue oxygen probe (Licox, Integra Neurosciences, USA) and that values are correlated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Brain injury (head trauma, SAH, ICH)
Key inclusion criteria (1 listed)
- Necessity of monitoring by PtiO2 and ICP
Key exclusion criteria (1 listed)
- Inability to apply NIRS sensor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
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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.
Henry BORET, MD principal investigator
Direction Centrale du Service de Santé des Armées
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 Brain Trauma and SAH, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
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: finished, as of the sponsor's last update on 16 Mar 2012. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 16 Mar 2012.