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

This study has been completed.
Sponsor:
Information provided by:
Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier:
NCT00703495
First received: June 19, 2008
Last updated: April 3, 2009
Last verified: April 2009
  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 (INVOS Somanetics 5100C)

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: 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

Resource links provided by NLM:


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 ]

Estimated Enrollment: 20
Study Start Date: July 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: transcranial oxygen saturation measurement (INVOS Somanetics 5100C)
    rSO2 measurement
    Other Name: INVOS Somanetics 5100C
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Spain
Hospital Universitario "Virgen del Rocío"
Seville, Spain, 41013
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

No publications provided by Hospitales Universitarios Virgen del Rocío

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Leal Noval, Santiago R., Hospitales Universitarios "Virgen del Rocio"
ClinicalTrials.gov Identifier: NCT00703495     History of Changes
Other Study ID Numbers: PI 06/2008
Study First Received: June 19, 2008
Last Updated: April 3, 2009
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)

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 20, 2014