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Completed

NCT Number: NCT00703495

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

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).

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Key information

Conditions

Brain Injuries Brain Diseases Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario "Virgen del Rocío"

Seville, 41013, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transcranial oxygen saturation measurement (INVOS Somanetics 5100C)

Device

rSO2 measurement

Other names: INVOS Somanetics 5100C

Primary outcomes

  1. correlation between rSO2 and PbtO2

    Time frame: four months

Secondary outcomes

  1. correlation between rSO2 and CPP

    Time frame: four months

Sponsors and collaborators

Lead sponsor

Hospitales Universitarios Virgen del Rocío

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 23, 2008
Registry last updated
Apr 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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