Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial oxygen saturation measurement (INVOS Somanetics 5100C) | Device | rSO2 measurement |
|
| Measure | Description | Time Frame |
|---|---|---|
| correlation between rSO2 and PbtO2 | four months |
| Measure | Description | Time Frame |
|---|---|---|
| correlation between rSO2 and CPP | four months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario "Virgen del Rocío" | Seville | Seville | 41013 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20502869 | Derived | 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. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 23, 2009 | |
| Reset | Aug 10, 2009 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 23, 2009 | Aug 10, 2009 |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
Not provided
Not provided
Not provided
Not provided
Not provided
| Hospital Universitario "Virgen del Rocío", Seville, Spain |
| Study Chair |
| Maria Dolores Rincón, M.D., PhD | Hospital Universitario "Virgen del Rocío", Seville, Spain | Study Chair |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |