Clinical Trials Directory

Trials / Completed

CompletedNCT00703495

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
20 (estimated)
Sponsor
Hospitales Universitarios Virgen del Rocío · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEtranscranial oxygen saturation measurement (INVOS Somanetics 5100C)rSO2 measurement

Timeline

Start date
2008-07-01
Primary completion
2009-04-01
Completion
2009-04-01
First posted
2008-06-23
Last updated
2009-04-06

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT00703495. Inclusion in this directory is not an endorsement.