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临床试验/NCT06036732
NCT06036732尚未招募不适用

The New Developed FIVE Score and Its Comparison With GCS and FOUR Scores Regarding Length of Hospital Stay Morbidity and Mortality in Neuro-intensive Care Patients. an Observational Prospective Study

Istanbul University - Cerrahpasa (IUC)1 个研究点 分布在 1 个国家目标入组 223 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
223
试验地点
1
主要终点
Modified Rankin Scale

研究概览

简要总结

  1. The primary aim of this study is to investigate the correlation between the length of ICU stay and a newly developed FIVE score in neuro-intensive care patients.
  2. The secondary objectives are to evaluate the impact of the FIVE score on hospital length of stay, Modified Rankin Scale, and mortality, as well as to determine the correlation between the GCS, FOUR, and FIVE scores

详细描述

Consciousness monitoring is crucial in neuro-intensive care. Despite the use of different scoring systems to establish a common language among evaluators, the Glasgow Coma Scale (GCS) remains the most widely used in clinical practice. In GCS evaluation, verbal response, motor response, and eye response are assessed. Another scoring system, FOUR (Full Outline of UnResponsiveness ) Score is similar to the Glasgow Coma Score (GCS). But it is designed to provide a more comprehensive neurological assessment. The FOUR score evaluates four areas: including eye opening, motor response, brainstem reflexes, and respiration, and assigns a score for each area. A comprehensive education regarding those scores was given the intensive care healthcare providers before the trial.

In this study, the investigators developed the Full Intracranial Validity Evaluation (FIVE) Score, by adding the mean arterial pressure and gag reflex components to the FOUR score. The investigators believe that this new score, which can be used for clinical monitoring, may offer an alternative to FOUR and GCS monitoring. According to this scoring system, in addition to the criteria for the FOUR score, patients with a mean arterial pressure between 60-130mmHg receive 2 points; patients under inotropic support with a mean arterial pressure between 60-130mmHg receive 1 point; patients with a mean arterial pressure below 60mmHg or above 130mmHg receive 0 points. Additionally, for patients with infratentorial mass, the investigators add the assessment of gag reflex in the calculation of the FIVE score. If the reflex is absent, 0 points are given; if it is unilateral, 1 point is given, and if it is preserved, 2 points are given.

The demographic data, diagnoses, systemic comorbidities, the American Society of Anaesthesiologists (ASA) score, the Charlson Comorbidity Index (CCI), and the APACHE II scores of patients were recorded.

The GCS, FOUR, and FIVE scores of the patients were recorded at neuro ICU admission, every 12 hours during neuro ICU follow-up period and discharge. In our clinic, GCS monitoring is routinely performed hourly for every patient admitted to the ICU. For patients with a decrease of two or more points in GCS score, FOUR and FIVE scores were re-evaluated and recorded without waiting for the 12 hours. Besides this, the worst, the best and the mean GCS, FOUR, and FIVE scores were recorded in the neuro ICU follow-up period. The assessment count of the GCS, FOUR, and FIVE scores during clinical follow-up was recorded.

The length of ICU and hospital stay were recorded. The Modified Rankin Scale of the patients was recorded six months after ICU discharge.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • between the ages of 18 and 80
  • who were monitored in the Neurosurgical Intensive Care Unit
  • had a history of ischemic or hemorrhagic stroke within the last 6 months
  • underwent infratentorial craniotomy
  • supratentorial craniotomy
  • endoscopic surgery
  • vascular surgery
  • epilepsy surgery
  • hydrocephalus surgery
  • neurovascular intervention

排除标准

  • patients over 80 years of age
  • under 18 years of age
  • patients who were sedated
  • patients who were administered neuromuscular blockers during intensive care follow-up
  • patients with diagnosed psychiatric illness
  • patients who were alcohol or drug addicts

结局指标

主要结局

Modified Rankin Scale

时间窗: six months after ICU discharge

In scoring post-discharge morbidity six months after intensive care unit discharge, Modified Rankin Score is used. minimum value:0, maximum value:6, higher scores mean a worse outcome

Change in FIVE Scores

时间窗: baseline, 12 hours intervals, up to an hour of ICU discharge

Full Intracranial Validity Evaluation, minimum value:0, maximum value: 20, higher scores mean a better situation

Change in GKS Scores

时间窗: baseline, 12 hours intervals, up to an hour of ICU discharge

Glasgow Coma Score, minimum value:3, maximum value: 15, higher scores mean a better situation

次要结局

未报告次要终点

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

merve tugba ozfidan donmez

medical doctor

Istanbul University - Cerrahpasa (IUC)

研究点 (1)

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