Is NIRS Able to Detect Ischemia Following Brain Insult

Brain Trauma Clinical Trial

— NIRS  

Official title:

The New 4 Wavelengths EQUANOX NIRS Sensor: Correlation and Detection of Ischemic Episodes. An Observational Comparative Study Versus PtiO2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556620
• Other study ID #: DCSSA
• Status: Completed
• Phase: N/A
• First received: March 15, 2012
• Last updated: March 15, 2012
• Start date: November 2011
• Est. completion date: January 2012

Study information

• Verified date: March 2012
• Source: Direction Centrale du Service de Santé des Armées
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: AFSSAPS
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Necessity of monitoring by PtiO2 and ICP

Exclusion Criteria:

• Inability to apply NIRS sensor

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Trauma
• ICH
• SAH

Locations

Country	Name	City	State
France	Sainte Anne Military Teaching Hospital	Toulon

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France,