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

Sponsored by:	Hospitales Universitarios Virgen del Rocío
Information provided by:	Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier:	NCT00703495

Purpose

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).

Condition	Intervention
Brain Injuries	Device: transcranial oxygen saturation measurement

MedlinePlus related topics: Traumatic Brain Injury

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Crossover, Cross-Sectional
Official Title:	Validation of Non- Invasive Regional Transcranial Oxygen Saturation (rSO2) by Comparison With Invasive Brain Tissue Oxygenation (PbtO 2) Measurement in Patients With Severe Traumatic Brain Injury

Further study details as provided by Hospitales Universitarios Virgen del Rocío:

Primary Outcome Measures:

correlation between rSO2 and PbtO2 [ Time Frame: four months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

correlation between rSO2 and CPP [ Time Frame: four months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	20
Study Start Date:	July 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

rSO2 measurement

Detailed Description:

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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703495

Contacts

Contact: Santiago R Leal-Noval, MD PhD	03455012528 ext 312528	sramon@cica.es
Contact: Aurelio Cayuela, MD PhD	03455013299 ext 313299	aurelio.cayuela.sspa@juntadeandalucia.es

Locations

Spain
Hospital Universitario "Virgen del Rocío"	Recruiting
Seville, Spain, 41013
Contact: Santiago R Leal-Noval, MD PhD 0-34-55012528 ext 312528 sramon@cica.es

Sponsors and Collaborators

Hospitales Universitarios Virgen del Rocío

Investigators

Principal Investigator:	Santiago R Leal-Noval, M.D., PhD	Hospital Universitario "Virgen del Rocío", Seville, Spain
Study Chair:	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 Director:	Francisco Murillo, M.D., PhD	Hospital Universitario "Virgen del Rocío", Seville, Spain
Study Chair:	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

More Information

Responsible Party:	Hospitales Universitarios "Virgen del Rocio" ( Leal Noval, Santiago R. )
Study ID Numbers:	PI 06/2008
Study First Received:	June 19, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00703495
Health Authority:	Spain: Ethics Committee

Keywords provided by Hospitales Universitarios Virgen del Rocío:

traumatic
brain injury
brain regional oxygen saturation (rSO2)
brain tissue oxygenation (PbtO2)
cerebral perfusion pressure (CPP)

Study placed in the following topic categories:

Craniocerebral Trauma
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases

Trauma, Nervous System
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009