NCT00703495

Brief Summary

The purpose of this study is to investigate the relationship among regional transcranial oxygen saturation (rSO2), brain tissue oxygen pressure (PbtO2) and cerebral perfusion pressure (CPP) in patients with severe traumatic brain injury (TBI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2008

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

First Submitted

Initial submission to the registry

June 19, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2008

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

April 6, 2009

Status Verified

April 1, 2009

Enrollment Period

9 months

First QC Date

June 19, 2008

Last Update Submit

April 3, 2009

Conditions

Brain Injuries

Keywords

traumaticbrain injurybrain regional oxygen saturation (rSO2)brain tissue oxygenation (PbtO2)cerebral perfusion pressure (CPP)

Outcome Measures

Primary Outcomes (1)

  • correlation between rSO2 and PbtO2

    four months

Secondary Outcomes (1)

  • correlation between rSO2 and CPP

    four months

Interventions

transcranial oxygen saturation measurement (INVOS Somanetics 5100C)DEVICE

rSO2 measurement

Also known as: INVOS Somanetics 5100C

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stable patients with severe traumatic brain injury (Glasgow Coma Scale \< 9) monitored through intracranial pressure (ICP) and brain tissue partial pressure of oxygen (PbtO2) probe, inserted for indications other than inclusion in this study

You may qualify if:

  • Severe Traumatic Brain Injury (Glasgow Coma Scale \< 9)
  • Having an intraparenchymal cerebral ICP/PbtO2 catheter previously inserted.
  • Expected length of ICU stay \> 1 days

You may not qualify if:

  • Patients necessitating ongoing resuscitation
  • End-stage in which death is imminent
  • Deficient signal of rSO2 impeding its proper valuation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario "Virgen del Rocío"

Seville, Seville, 41013, Spain

Location

Related Publications (1)

  • Leal-Noval SR, Cayuela A, Arellano-Orden V, Marin-Caballos A, Padilla V, Ferrandiz-Millon C, Corcia Y, Garcia-Alfaro C, Amaya-Villar R, Murillo-Cabezas F. Invasive and noninvasive assessment of cerebral oxygenation in patients with severe traumatic brain injury. Intensive Care Med. 2010 Aug;36(8):1309-17. doi: 10.1007/s00134-010-1920-7. Epub 2010 May 26.

    PMID: 20502869DERIVED

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

  • Santiago R Leal-Noval, M.D., PhD

    Hospital Universitario "Virgen del Rocío", Seville, Spain

    PRINCIPAL INVESTIGATOR

  • Aurelio Cayuela, M.D., PhD

    Hospital Universitario "Virgen del Rocío", Seville, Spain

    STUDY CHAIR

  • Victoria Arellano, M.D., PhD

    Hospital Universitario "Virgen del Rocío", Seville, Spain

    STUDY CHAIR

  • Yael Corcia, M.D.

    Hospital Universitario "Virgen del Rocío", Seville, Spain

    STUDY CHAIR

  • Vicente Padilla, M.D.

    Hospital Universitario "Virgen del Rocío", Seville, Spain

    STUDY CHAIR

  • Claudio Garcia-Alfaro, M.D., PhD

    Hospital Universitario "Virgen del Rocío", Seville, Spain

    STUDY CHAIR

  • Antonio Marín, M.D., PhD

    Hospital Universitario "Virgen del Rocío", Seville, Spain

    STUDY CHAIR

  • Francisco Murillo, M.D., PhD

    Hospital Universitario "Virgen del Rocío", Seville, Spain

    STUDY DIRECTOR

  • Rosario Amaya, M.D., PhD

    Hospital Universitario "Virgen del Rocío", Seville, Spain

    STUDY CHAIR

  • Maria Dolores Rincón, M.D., PhD

    Hospital Universitario "Virgen del Rocío", Seville, Spain

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 19, 2008

First Posted

June 23, 2008

Study Start

July 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

April 6, 2009

Record last verified: 2009-04

Locations

ES(1)