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临床试验/NCT07832773
NCT07832773尚未招募不适用

Replacing GCS With FOUR in ICU Severity Scores: Derivation and Validation of Modified APACHE, SAPS, MODS, LODS, and SOFA Models

Al-Nahrain University1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2026年11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
2,000
试验地点
1
主要终点
In hospital mortality

研究概览

简要总结

The goal of this observational study is to evaluate whether the Full Outline of UnResponsiveness (FOUR) score can replace the Glasgow Coma Scale (GCS) as the neurologic component of established intensive care unit (ICU) severity scoring systems and to derive and validate modified APACHE, SAPS, MODS, LODS, and SOFA models incorporating the FOUR score in critically ill adult patients.

The main questions it aims to answer are:

Does replacing the GCS with the FOUR score provide comparable or improved discrimination for in-hospital mortality across established ICU severity scoring systems? Can FOUR-based modifications of APACHE, SAPS, MODS, LODS, and SOFA be successfully derived and validated with adequate discrimination, calibration, and overall predictive performance? Do the modified FOUR-based models demonstrate predictive performance comparable to or different from the corresponding original GCS-based models?

Researchers will compare the performance of the modified FOUR-based models with their original GCS-based counterparts to determine whether substitution of the FOUR score provides valid and clinically useful risk prediction in critically ill adults.

Participants will not receive an experimental intervention. Data routinely collected during ICU care will be used to:

Calculate the original GCS-based APACHE, SAPS, MODS, LODS, and SOFA scores. Replace the GCS component with the FOUR score and derive the corresponding modified models.

Evaluate and validate the predictive performance of the original and modified models using measures of discrimination, calibration, and overall predictive accuracy.

详细描述

Intensive care units (ICUs) are highly complex, resource and technology intensive settings. During the 1970s and 1980s, increasing intensive care costs and poor outcomes among patients with multiple organ failure created a need for tools to measure illness severity and patient outcomes. Intensive care unit mortality varies considerably worldwide, with rates of 16.2% in large international study and 19.1% in a European cohort study, while higher mortality was reported in developing countries, Ethiopia (39.06%) and Iraq (29.8%).

The Glasgow Coma Scale (GCS) assesses impaired consciousness using eye opening, verbal, and motor responses and is widely used for assessment, triage, monitoring, and communication among healthcare professionals. It has several limitations, verbal component cannot be assessed reliably in patients who are intubated, pharmacologically sedated, or unable to speak, limiting the use of the total score for prognosis. Also has limitation in evaluation patients with concomitant head and spinal cord injury. Drug and alcohol intoxication can also affect GCS assessment and should be considered when interpreting scores. In addition, Aphasia, paralysis, neuromuscular weakness, and spinal injuries may impair verbal or motor responses independently of consciousness, while painful stimuli can complicate scoring in polytrauma patients. Its reliability depends on assessor training, the patient's consciousness level, and the type of stimulus used.

The Full Outline of UnResponsiveness (FOUR) score consisting of four components: eye response, motor response, brainstem reflexes, and respiration, with each component assigned a maximum score of 4. It showed excellent interrater reliability (weighted kappa = 0.82), and provide greater neurological detail and identification of severe impairment than GCS. In non-traumatic patients, FOUR score showed better mortality discrimination than GCS (AUROC 0.799 vs. 0.731), and offers advantages in intubated patients because it evaluates brainstem reflexes and respiratory patterns. FOUR also showed better mortality prediction than GCS in traumatic brain injury, neurosurgical, and acute brain-injury patients, with AUROC values of 0.93 vs. 0.89, 0.768 vs. 0.699, and 0.835 vs. 0.772, respectively.

The Acute Physiology and Chronic Health Evaluation (APACHE) assess risk of in-hospital by using pre-admission health status and 34 physiological variables collected during the first 24 hours of ICU admission. The Acute Physiology and Chronic Health Evaluation II (APACHE II) uses 12 physiological variables, along with age and previous health status, to calculate a score from 0-71, with higher scores indicating greater illness severity and mortality risk. APACHE III incorporated over 100 variables, while APACHE IV added further clinical factors and enabled prediction of hospital mortality and ICU length of stay.

The Simplified Acute Physiology Score (SAPS) includes14 physiological variables collected during the first 24 hours of ICU admission to provides a simple measure of the risk of death among critically ill patients. The Simplified Acute Physiology Score II (SAPS II) provide an objective assessment of illness severity and an estimate of hospital mortality among critically ill patients. SAPS II involve 17 variables, including 12 physiological measurements, age, type of ICU admission, and three underlying disease conditions: acquired immunodeficiency syndrome, metastatic cancer, and hematologic malignancy. SAPS 3, incorporated 20 variables and provided region-specific mortality prediction for international use.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients for whom sufficient clinical and physiological data are available to calculate the original APACHE, SAPS, MODS, LODS, and SOFA scores.
  • •Patients with a documented mortality outcome.

排除标准

  • •Patients transferred from another hospital after initial resuscitation.
  • •Patients who died before the required initial clinical assessment.

结局指标

主要结局

In hospital mortality

时间窗: In-Hospital Phase (average of 20 days through discharge)

Mortality (death) during hospitalization

次要结局

未报告次要终点

研究者

发起方
Al-Nahrain University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdulillah R. Khamees

Principal Investigator

Al-Nahrain University

研究点 (1)

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