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临床试验/NCT03144219
NCT03144219招募中不适用

A Novel Non-invasive Technique of Cerebral Compliance and Auto-regulation Assessment

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2017年5月1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
133
试验地点
1
主要终点
Impaired cerebral compliance

研究概览

简要总结

Introduction: Intracranial pressure (ICP) monitoring is essential in several medical situations, however, currently there is an invasive technique, costly, not widely available and sometimes contraindicated. Transcranial Doppler (TCD) pulsatility index (PI) measure can provide indirect information on the cerebrovascular resistance (CVR) augmentation, which is present concomitantly with intracranial hypertension (ICH). The hypothesis that PI measure accurately indicates cerebral compliance impairment (CCI) has been not assessed by large studies currently, and would be of value as a non invasive technique to denote earlier installing of therapeutics to prevent the effects of ICH. Likewise, a novel technique of intracranial compliance assessment by means of an external sensor has been developed, still in need of being prospectively studied.

Objective: The present study aims to assess PI accuracy indicating CCI, and dynamic cerebral auto regulation (dCAR) during internal jugular veins (IJVs) compression observed by both invasive and non-invasive techniques.

Methods: A prospective, observational controlled study, including critical neurological patients with ICP monitoring in normal range (under 20 mmHg). Initially, dCAR is monitored, then, the IJVs are compressed for 60 seconds with ultrasound guidance. We evaluate optic nerve sheath prior to intervention, and dCAR, ICP values, ICP waveforms and PI variation at different times, correlating results.

详细描述

Introduction

Multimodal monitoring in neurocritical care is essential in current practice. It aims to early Identify treats occurring in the brain of comatose patients and implement targeted therapies to avoid further complications and poorer outcomes.

Some of the methods used for monitoring require invasive procedures, such as the assessment of intracranial pressure (ICP) with intracranial catheter. However, these techniques can raise morbidity, are costly, and are not available or contraindicated1. In addition, the invasive ICP method is not perfectly accurate with cases in which, intracranial hypertension (ICH) may be present despite normal screen ICP values2.

Transcranial Doppler (TCD) is a noninvasive bedside ultrasound technique which could be implemented in the monitoring of raised ICP3-4 and in the identification of impaired intracranial compliance by the compression of the internal jugular veins (IJVs)1. However, such application of the method has not been validate with large prospective studies. Validation of this technique would be of value for screening patients prior to suffer the consequences of ICH.

Recently, a non-invasive cranial strain gauge sensor has been developed, able to provide the curves of cardiac beat by beat cranial dilation. The sensor registers have been demonstrated to be similar to those obtained by the invasive ICP catheters, although large series comparing both techniques are lacking.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients whose underwent ICP monitoring displaying both ICP curves and values.

排除标准

  • Patients whose display absence of insonation window

结局指标

主要结局

Impaired cerebral compliance

时间窗: 10 minutes

Performing ICP and TCD monitoring simultaneously during jugular compression, matching waveform behavior through computer software QL Online

次要结局

  • Impaired cerebral auto-regulation(10 minutes)
  • Non-invasive intracranial compliance monitoring(10 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sergio Brasil, MD

Sergio Brasil

University of Sao Paulo

研究点 (1)

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