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临床试验/NCT05804773
NCT05804773招募中不适用

Cerebral Perfusion Variation During Blood Pressure Changes in ICU: Relationship Between Transcranial Doppler, Frontal EEG and Cerebral Oximetry: a Prospective Observational Study

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2023年7月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
92
试验地点
1
主要终点
Burst suppression

研究概览

简要总结

The risk associated with arterial hypotension during anesthesia for intensive care sedation has been demonstrated, but the threshold at which consequences for perfusion of one or more organs appear varies according to the mechanism of hypotension, associated abnormalities (HR, cardiac output and oxygen transport) and the patient's terrain.

Currently, a mean arterial pressure greater than 60 mm Hg (1) and a reduction of less than 30-50% from the value measured before sedation are commonly used to ensure good perfusion of all organs. In intensive care, it is recommended to maintain a MAP between 60 and 70 mmHg and a Cerebral Perfusion Pressure (CPP) > 50 mmHg for neurocompromised patients with Intra Cranial pressure (ICP) measure. Normally, cerebral blood flow is self-regulated, allowing adaptation of cerebral blood flow to oxygen requirements at different levels of high and low blood pressure. However, this protective mechanism may fail for a degree of hypotension that depends on several factors such as the age or vascular status of the patient.

The aim of the study is to measure non-invasively, easily and reliably the variations of cerebral perfusion in patients with or without cardiovascular risk factors during controlled variations performed during routine care to set the blood pressure level within the recommended safety standards during sedation in intensive care unit.

What is the tolerable target BP level for a patient under continuous sedation in the ICU? Is there a simple and non-invasive way to measure the level of cerebral blood flow autoregulation and especially the adequacy of the brain's oxygen requirements?

详细描述

The risk associated with arterial hypotension during anesthesia for intensive care sedation has been demonstrated, but the threshold at which consequences for perfusion of one or more organs appear varies according to the mechanism of hypotension, associated abnormalities (HR, cardiac output and oxygen transport) and the patient's terrain.

Currently, a mean arterial pressure greater than 60 mm Hg (1) and a reduction of less than 30-50% from the value measured before sedation are commonly used to ensure good perfusion of all organs. In intensive care, it is recommended to maintain a MAP between 60 and 70 mmHg and a Cerebral Perfusion Pressure (CPP) > 50 mmHg for neurocompromised patients with Intra Cranial pressure (ICP) measure. Normally, cerebral blood flow is self-regulated, allowing adaptation of cerebral blood flow to oxygen requirements at different levels of high and low blood pressure. However, this protective mechanism may fail for a degree of hypotension that depends on several factors such as the age or vascular status of the patient.

The aim of the study is to measure non-invasively, easily and reliably the variations of cerebral perfusion in patients with or without cardiovascular risk factors during controlled variations performed during routine care to set the blood pressure level within the recommended safety standards during sedation in intensive care unit. Cerebral perfusion and cerebral O2 adequacy will be compared and assessed by continuous and simultaneous measurements of cerebral blood flow by transcranial Doppler (CTD), cerebral O2 adequacy by near-infrared spectroscopy (NIRS) and a parameter of cerebral function by electroencephalogram (EEG) - frontal EEG.

The objective for a given patient is to detect a possible threshold pressure value that could impact blood flow velocity (Doppler) and possibly EEG and cerebral oximetry.

This clinical research is carried out on adult patients hospitalized in intensive care. Their non-opposition to participate in this study will be collected during the hospitalization or, if necessary, the trusted person/relative of a patient unable to express his/her will. The protocol starts after at least 12 hours of stablisation in the intensive care unit.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (> 18 years old)
  • Requiring an intensive care unit admission
  • Informed patient who has expressed his/her non-opposition to participating in this research or, if applicable, trusted person/relative of patient unable to express his/her wishes

排除标准

  • Patients under 18 years of age.
  • Patient, or if applicable, trusted person / close relative / parent of patient unable to express his/her will, opposed to participation in the protocol
  • Pregnant woman
  • Patient under judicial protection
  • Patient not affiliated to a social health system

结局指标

主要结局

Burst suppression

时间窗: 1 day

Continuous measurement of burst suppression (BS) (%)

95% spectral frequency front

时间窗: 1 day

Continuous measurement of spectral frequency front (SEF95) on the frontal EEG

Mean arterial pressure

时间窗: 1 day

Continuous non-invasive measurement of mean arterial pressure (MAP, mmHg)

Cerebral blood velocity in the middle cerebral artery

时间窗: 1 day

Measurement of cerebral blood velocity in the middle cerebral artery by transcranial pulsed Doppler (TCD) (Mean velocity, Vm, cm/s)

delivered doses of hypnotics, morphine and paralytic agents

时间窗: 1 day

Quantification of delivered doses of hypnotics, morphine and paralytic agents

次要结局

  • Cerebral O2 saturation(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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