Invasive and Non-Invasive Assessment of Cerebral Oxygenation in Patients With Severe Traumatic Brain Injury (TBI)

NCT ID: NCT00703495

Last Updated: 2009-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-04-30

Brief Summary

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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).

Detailed Description

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Experience with rsO2 assessed by near infrared spectroscopy (NIRS) in patients with severe TBI is lacking. Reports about the usefulness of rSO2 are contradictory as regards its technical reliability and clinical value. Continuous time-domain analysis comparing rSO2, PbtO2 and CPP has never been carried out and the correlation among these variables remains largely unknown. A significant association between rSO2 and these clinically important variables would suggest that cerebral oximetry provides relevant data signifying that rSO2 might be a useful tool assessing cerebral oxygenation in selected patients with TBI.

Conditions

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Brain Injuries

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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transcranial oxygen saturation measurement (INVOS Somanetics 5100C)

rSO2 measurement

Intervention Type DEVICE

Other Intervention Names

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INVOS Somanetics 5100C

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patient's relatives refusal to patient's inclusion in the study
* Patients necessitating ongoing resuscitation
* End-stage in which death is imminent
* Deficient signal of rSO2 impeding its proper valuation
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospitales Universitarios Virgen del Rocío

OTHER

Sponsor Role lead

Responsible Party

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Hospitales Universitarios "Virgen del Rocio"

Principal Investigators

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Santiago R Leal-Noval, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario "Virgen del Rocío", Seville, Spain

Aurelio Cayuela, M.D., PhD

Role: STUDY_CHAIR

Hospital Universitario "Virgen del Rocío", Seville, Spain

Victoria Arellano, M.D., PhD

Role: STUDY_CHAIR

Hospital Universitario "Virgen del Rocío", Seville, Spain

Yael Corcia, M.D.

Role: STUDY_CHAIR

Hospital Universitario "Virgen del Rocío", Seville, Spain

Vicente Padilla, M.D.

Role: STUDY_CHAIR

Hospital Universitario "Virgen del Rocío", Seville, Spain

Claudio Garcia-Alfaro, M.D., PhD

Role: STUDY_CHAIR

Hospital Universitario "Virgen del Rocío", Seville, Spain

Antonio Marín, M.D., PhD

Role: STUDY_CHAIR

Hospital Universitario "Virgen del Rocío", Seville, Spain

Francisco Murillo, M.D., PhD

Role: STUDY_DIRECTOR

Hospital Universitario "Virgen del Rocío", Seville, Spain

Rosario Amaya, M.D., PhD

Role: STUDY_CHAIR

Hospital Universitario "Virgen del Rocío", Seville, Spain

Maria Dolores Rincón, M.D., PhD

Role: STUDY_CHAIR

Hospital Universitario "Virgen del Rocío", Seville, Spain

Locations

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Hospital Universitario "Virgen del Rocío"

Seville, Seville, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 20502869 (View on PubMed)

Other Identifiers

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PI 06/2008

Identifier Type: -

Identifier Source: org_study_id

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