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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00703495
Enrollment
20
Registered
2008-06-23
Start date
2008-07-31
Completion date
2009-04-30
Last updated
2009-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries

Keywords

traumatic, brain injury, brain regional oxygen saturation (rSO2), brain tissue oxygenation (PbtO2), cerebral perfusion pressure (CPP)

Brief 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.

Interventions

DEVICEtranscranial oxygen saturation measurement (INVOS Somanetics 5100C)

rSO2 measurement

Sponsors

Hospitales Universitarios Virgen del Rocío
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
correlation between rSO2 and PbtO2four months

Secondary

MeasureTime frame
correlation between rSO2 and CPPfour months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026