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临床试验/NCT02015741
NCT02015741撤回不适用

Comparability of Bispectral Index and NeuroSENSE in Aged Patients

Hopital Foch2 个研究点 分布在 1 个国家开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
Hopital Foch
试验地点
2
主要终点
Percentage of patients with a high concordance between pairs of Bispectral Index and NeuroSENSE indices

研究概览

简要总结

The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic parameters. Nowadays it can be evaluated by several monitoring methods, derived from electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton, USA). A new modality is currently under development: the NeuroSENSE (Cleveland Medical Devices Inc., Cleveland, OH 44103, USA).

Use of such devices is discussed in aged patients. The purpose of this study is to compare Bispectral Index and NeuroSENSE during awake periods and during natural sleep.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients older than 74 years

排除标准

  • pace-maker

结局指标

主要结局

Percentage of patients with a high concordance between pairs of Bispectral Index and NeuroSENSE indices

时间窗: 1 year

Statistical analysis of concordance between pairs of Bispectral Index and NeuroSENSE indices (high concordance when \> 0.60%)

次要结局

  • Percentage of patients with a high concordance between pairs of Bispectral Index and NeuroSENSE indices during periods of natural sleep(1 year)

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (2)

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