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NCT00703495 Clinical Trial

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

Brain Injuries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00703495
Other study ID # PI 06/2008
Secondary ID
Status Completed
Phase N/A
First received June 19, 2008
Last updated April 3, 2009
Start date July 2008
Est. completion date April 2009

Study information
Verified date April 2009
Source Hospitales Universitarios Virgen del Rocío
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• transcranial oxygen saturation measurement (INVOS Somanetics 5100C)
rSO2 measurement

Locations
Country Name City State
Spain Hospital Universitario "Virgen del Rocío" Seville

Sponsors (1)
Lead Sponsor Collaborator
Hospitales Universitarios Virgen del Rocío

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary correlation between rSO2 and PbtO2 four months
Secondary correlation between rSO2 and CPP four months
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