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
Verified date | April 2009 |
Source | Hospitales Universitarios Virgen del Rocío |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario "Virgen del Rocío" | Seville |
Lead Sponsor | Collaborator |
---|---|
Hospitales Universitarios Virgen del Rocío |
Spain,
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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