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临床试验/NCT00713375
NCT00713375Unknown不适用

Multiscale Entropy and Time-Frequency Analysis of Electrocardiogram and Blood Pressure in Patients With Spontaneous Intracranial Hemorrhage

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Activity of autonomic nervous activities determined by low frequency and high frequency energies in heart rate variability

研究概览

简要总结

Dysregulation of autonomic nervous system is evident in patients with spontaneous intracranial hemorrhage. In this study, we utilize a non-invasive method (heart rate and blood pressure variability analysis to analyze the autonomic activities in this group of neurosurgical patients. Our aim is to determine the utility of this modality in risk stratification and outcome prediction in these patients.

详细描述

Spontaneous intracranial hemorrhage is an absolute emergency in the field of neurosurgery, and it is also a devastating event that commonly results in major neurological disabilities or mortalities. Since disease severities and clinical courses vary in each patient, pathophysiological studies and prognostic factors are always worth research. From previous studies, we know that dysregulation of autonomic system plays an important role in intracranial hemorrhage. Hemorrhage itself is associated with sympathoexcitation, and patients who develop rebleeding or infarction complications are found to have an even higher degree of sympathetic storm. Therefore, the degree of autonomic activities seems to be a useful predictor.

Traditionally, sympathetic activities are measured by plasma catecholamine, while parasympathetic activities are hard to measure. In recent decades, the application of engineering in biological fields makes a great breakthrough. Waveform analysis of biological signals, such as electrocardiograms and arterial blood pressure, can indirectly determine autonomic activities. The variabilities of heart rate and blood pressure are subjected to frequency analysis. This generates several dominant frequency bands. High frequency bands (0.15-0.40Hz) are attributed to the effect of parasympathetic nervous system, while, the low frequency bands (0.04-0.15 Hz) are attributed to the effect of both sympathetic and parasympathetic nervous systems.

In this study, all patients with spontaneous intracranial bleedings undergo standard treatment and monitoring. This include electrocardiography, arterial blood pressure, and cerebral blood flow using transcranial Doppler sonography. For those who also have intracranial pressure monitoring, the intracranial pressure are also recorded. All these biological signals are exported for wave form analysis. We use frequency analysis, time-frequency analysis, and multiscale entropy to analyze these data. The results of analyses were also correlated to plasma catecholamine levels, proinflammatory markers, as well as the clinical variables. Our aim is to identify predictors of complications and grave outcomes from these biological signals. We also apply the results for future pathophysiological studies.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Spontaneous intracranial hemorrhage with radiographical confirmation

排除标准

  • Traumatic or undefined mechanisms for intracranial hemorrhage
  • Pre-existing cardiac arrythmia
  • Patients who had previous histories of intracranial, cardiac, hepatic, renal, or lung diseases

结局指标

主要结局

Activity of autonomic nervous activities determined by low frequency and high frequency energies in heart rate variability

时间窗: 14 days within initial ictus

次要结局

  • Presence of vasospasm or not(14 weeks)

研究者

申办方类型
Other

研究点 (2)

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