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Is NIRS Able to Detect Ischemia Following Brain Insult

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BORET Henry, Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier:
NCT01556620
First received: March 15, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  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

Resource links provided by NLM:

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources

Further study details as provided by 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 15, 2012
Last Updated: March 15, 2012
Health Authority: France: AFSSAPS

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

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

ClinicalTrials.gov processed this record on May 19, 2013