跳至主要内容
临床试验/NCT00703495
NCT00703495已完成不适用

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

Hospitales Universitarios Virgen del Rocío1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
correlation between rSO2 and PbtO2

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Severe Traumatic Brain Injury (Glasgow Coma Scale < 9)
  • Having an intraparenchymal cerebral ICP/PbtO2 catheter previously inserted.
  • Expected length of ICU stay > 1 days

排除标准

  • 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

结局指标

主要结局

correlation between rSO2 and PbtO2

时间窗: four months

次要结局

  • correlation between rSO2 and CPP(four months)

研究者

发起方
Hospitales Universitarios Virgen del Rocío
申办方类型
Other

研究点 (1)

Loading locations...

相似试验

Invasive and Non-Invasive Assessment of Cerebral... | 临床试验