Cerebral Autoregulation in Non Neurological Critical Patients.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To describe the incidence of impairment of cerebral autoregulation in critically ill patients.
研究概览
简要总结
Brief Summary Cerebral Autoregulation is a well known physiological response to blood pressure changes to maintain the cerebral perfusion. The critically ill patients are submitted to different situations that can impair the cerebral autoregulation as sepsis, sedation drugs and mechanical ventilation.
The delirium on ICU has been described as a bad prognosis factor, increasing the mortality and length of stay. The physiopathology of delirium has been related to cerebral perfusion. The delirium has been related to long term cognitive impairment.
Material and Methods:
This is a physiological prospective study that will be done in a 14 bed medical-surgical ICU. The investigators will enroll 100 ventilated patients, septic and non-septic. The investigators will measure cerebral autoregulation every 48-72 hours from admission on ICU. Neurological biomarkers (Neurological Specific Enolase, S100 beta and Vascular Endothelial Growing Factor) will be done at inclusion, 72 hours and 7 days. Clinical data, delirium presence, analytic data and ventilatory parameters will be registered every day.
At hospital discharge, a psychologist will do a cognitive evaluation using specific tests. The cognitive evaluation will be repeated at 3, 6 and 12 months.
Anticipate results:
Some items like mechanical ventilation, sepsis and sedation can impair cerebral autoregulation. The impairment of cerebral autoregulation is related to delirium in ICU and long cognitive impairment.
详细描述
Introduction:
Cerebral Autoregulation (CA) is the physiological strategy used for the brain to maintain the cerebral blood flow constant during blood pressure (BP) changes. The evaluation of CA dynamic and static models has been described in the literature. The coefficient Sx and the Mx are one of the validated dynamic methods. These coefficients are obtained from the correlation between BP and Middle Cerebral Artery (MCA) velocity measured using Transcranial Doppler (TCD). Correlation values higher than 0.3 reflect an impairment of CA.
The incidence of CA impairment in the Intensive Care Unit (ICU) is not well described. Neither, risk factors or clinical situations that precipitate CA impairment have been studied.
Mechanical Ventilation (MV) is a common treatment in the ICU. The main difference is the positive pressure administrated to the lungs instead of the negative pressure in spontaneous breathing. The positive pressure applied in the alveoli causes a local and systemic inflammatory response. Lung injuries are well described due to MV. Some studies relate changes in the Intracranial Pressure (ICP) and Cerebral Perfusion Pressure (CPP) with the Positive End- Expiratory Pressure in neurological patients. Also changes in the MCA velocity have been described with MV. The studies speculate that the changes are related to the intrathoracic positive pressure. However, all studies are in patients with acute neurological pathology.
In the ICU sedation drugs are often used to guarantee patient comfort in the MV. The BIS ® device is used for monitoring sedation level based on the electroencephalogram drawing. Recent studies analyse the influence of this drugs on CA in healthy volunteers. However, no studies have described the effects of long sedations like usually occurs in ICU.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years old of age.
- •Patients under mechanical ventilation and/or sedation drugs and/or severe sepsis as defined on international criteria.
- •Patients with arterial line.
排除标准
- •Acute neurological pathology.
- •Absence of arterial line.
- •Severe haemodynamic instability defined as Mean Arterial Pressure (MAP) lower than 70 mmHg even with pressors.
- •Absence of temporal bone window for doing TCD.
结局指标
主要结局
To describe the incidence of impairment of cerebral autoregulation in critically ill patients.
时间窗: 7 days
次要结局
- To describe the incidence of delirium in critically ill patients with or without impairment of cerebral autoregulation(30 days)
- To describe the long term cognitive impariment in critically ill patients.(3, 6 and 12 months)
研究者
Rafael Fernandez
Physician Doctor
Althaia Xarxa Assistencial Universitària de Manresa