Clinical trial NCT00703495: Invasive and Non-Invasive Assessment of Cerebral Oxygenation in Patients With Severe Traumatic Brain Injury (TBI)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries
Keywords: traumatic
brain injury
brain regional oxygen saturation (rSO2)
brain tissue oxygenation (PbtO2)
cerebral perfusion pressure (CPP)
Lead sponsor: Hospitales Universitarios Virgen del Rocío
Sponsor class: OTHER
First posted: 2008-06-23
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
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

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).

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 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

Primary outcomes:
measure: correlation between rSO2 and PbtO2
timeFrame: four months
Secondary outcomes:
measure: correlation between rSO2 and CPP
timeFrame: four months
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Hospital Universitario "Virgen del Rocío"
Study officials:
affiliation: Hospital Universitario "Virgen del Rocío", Seville, Spain
name: Santiago R Leal-Noval, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario "Virgen del Rocío", Seville, Spain
name: Aurelio Cayuela, M.D., PhD
role: STUDY_CHAIR
affiliation: Hospital Universitario "Virgen del Rocío", Seville, Spain
name: Victoria Arellano, M.D., PhD
role: STUDY_CHAIR
affiliation: Hospital Universitario "Virgen del Rocío", Seville, Spain
name: Yael Corcia, M.D.
role: STUDY_CHAIR
affiliation: Hospital Universitario "Virgen del Rocío", Seville, Spain
name: Vicente Padilla, M.D.
role: STUDY_CHAIR
affiliation: Hospital Universitario "Virgen del Rocío", Seville, Spain
name: Claudio Garcia-Alfaro, M.D., PhD
role: STUDY_CHAIR
affiliation: Hospital Universitario "Virgen del Rocío", Seville, Spain
name: Antonio Marín, M.D., PhD
role: STUDY_CHAIR
affiliation: Hospital Universitario "Virgen del Rocío", Seville, Spain
name: Francisco Murillo, M.D., PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario "Virgen del Rocío", Seville, Spain
name: Rosario Amaya, M.D., PhD
role: STUDY_CHAIR
affiliation: Hospital Universitario "Virgen del Rocío", Seville, Spain
name: Maria Dolores Rincón, M.D., PhD
role: STUDY_CHAIR
References:
citation: 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.