跳至主要内容
临床试验/NCT06043167
NCT06043167进行中(未招募)不适用

Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury. - a Prospective Observational Mono-center Cohort Study

Surgut Clinical Trauma Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年9月8日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
200
试验地点
1
主要终点
The interrater reliability of russian rendition the FOUR score

研究概览

简要总结

The aim of this study is to increase the effectiveness of clinical monitoring of patients with acute cerebral insufficiency by improving the discriminative ability of the FOUR scale. To study the sensitivity and specificity of the FOUR scale as a clinimetric of chronic disorders of consciousness.

详细描述

The key step in choosing a strategy for treating acute cerebral insufficiency is the assessment of the severity of cerebral damage and prognosis. The importance of correcting the severity of damage and prognosis for the choice of treatment strategy is beyond doubt.

At the same time, the complexity of objective evaluation is preserved throughout the world, after more than 40 years, has become an integral part of clinical practice worldwide. The findings obtained using GCS showed a strong relationship with those obtained using other indicators of severity and outcome. Although the scale of Glasgow coma is considered routine method, it has a number of significant drawbacks.

First, the verbal response of GCS tests often becomes inadequate in psychomotor-excited patients. On the contrary, in many patients with depressed consciousness, the verbal response is insufficient. Moreover, the GSC verbal response assessment cannot be applied to critical patients or those who have undergone intubation.

Secondly, and most importantly, GSC does not assess brain stem reflexes, eye movements, or complex motor responses in patients with altered consciousness. In addition, the GCS score is numerically skewed toward the motor response (the maximum number of points given for the motor response). These deficiencies previously caused repeated attempts to improve GCS: reaction level scale (RLS85), comprehensive consciousness level Scale (CLOCS), clinical neurological assessment (CNA) , Coma Recovery Scale (CRS), Glasgow-Liege Scale (GLS), Innsbruck Coma Scale (ICS), 15 and 60-second test (SST). Similar scans, tests are very long and laborious. None of these subsequently gained enough weight to replace GCS.

Third, despite the fact that GSC is regularly used in therapeutic and surgical intensive care units and resuscitation units, as well as the fact that it is usually used in conjunction with the APACHE system assessment, reliability in predicting outcomes in patients is unsatisfactory. Fourthly, Rowley and Fielding found that the reliability of the GCS score increases with the experience of its users and that user inexperience is associated with a high error rate.

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

  • acute brain failure after stroke or acute brain trauma

排除标准

  • the inability to assess the factors included in the study.
  • cardiopulmonaryresuscitation
  • arterial hypotension
  • hypoxemia
  • malignant hyperthermia or hypothermia

结局指标

主要结局

The interrater reliability of russian rendition the FOUR score

时间窗: 2023 - 2024

次要结局

未报告次要终点

研究者

发起方
Surgut Clinical Trauma Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrey Belkin

MDRussian Federation of Anesthesiologists and Reanimatologists

Ural State Medical University

研究点 (1)

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