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Is NIRS Able to Detect Ischemia Following Brain Insult (NIRS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01556620
First Posted: March 16, 2012
Last Update Posted: March 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
BORET Henry, Direction Centrale du Service de Santé des Armées
  Purpose
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.

Condition
Brain Trauma SAH ICH

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The New 4 Wavelengths EQUANOX NIRS Sensor: Correlation and Detection of Ischemic Episodes. An Observational Comparative Study Versus PtiO2

Further study details as provided by BORET Henry, Direction Centrale du Service de Santé des Armées:

Enrollment: 8
Study Start Date: November 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Brain injury (head trauma, SAH, ICH)
Criteria

Inclusion Criteria:

  • Necessity of monitoring by PtiO2 and ICP

Exclusion Criteria:

  • Inability to apply NIRS sensor
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556620


Locations
France
Sainte Anne Military Teaching Hospital
Toulon, France, 83000
Sponsors and Collaborators
Direction Centrale du Service de Santé des Armées
Investigators
Principal Investigator: Henry BORET, MD Direction Centrale du Service de Santé des Armées
  More Information

Responsible Party: BORET Henry, Médecin en Chef, Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier: NCT01556620     History of Changes
Other Study ID Numbers: DCSSA
First Submitted: March 15, 2012
First Posted: March 16, 2012
Last Update Posted: March 16, 2012
Last Verified: March 2012

Keywords provided by BORET Henry, Direction Centrale du Service de Santé des Armées:
PtiO2
NIRS

Additional relevant MeSH terms:
Brain Injuries, Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries