NCT01556620

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2012

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

Enrollment Period

2 months

First QC Date

March 15, 2012

Last Update Submit

March 15, 2012

Conditions

Brain TraumaSAHICH

Keywords

PtiO2NIRS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Brain injury (head trauma, SAH, ICH)

You may qualify if:

  • Necessity of monitoring by PtiO2 and ICP

You may not qualify if:

  • Inability to apply NIRS sensor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sainte Anne Military Teaching Hospital

Toulon, 83000, France

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Henry BORET, MD

    Direction Centrale du Service de Santé des Armées

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Médecin en Chef

Study Record Dates

First Submitted

March 15, 2012

First Posted

March 16, 2012

Study Start

November 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

March 16, 2012

Record last verified: 2012-03

Locations

FR(1)