Development and Validation of a Novel FOUR-Rapid Emergency Medicine Score (fREMS) for Mortality Prediction in Traumatic Brain Injury Patients
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
This prospective observational study aims to develop and internally validate a new clinical score, the FOUR-Rapid Emergency Medicine Score (fREMS), for predicting in-hospital mortality in patients with traumatic brain injury (TBI). The study will assess whether combining the Full Outline of UnResponsiveness (FOUR) score with physiological and clinical parameters from the Rapid Emergency Medicine Score (REMS) can improve early mortality prediction. The main question it aims to answer is:
Can the fREMS score accurately predict the risk of in-hospital mortality in patients with traumatic brain injury?
Data on demographic characteristics, vital signs, neurological assessment, and other relevant clinical variables will be collected from eligible patients with TBI and used to develop and validate the fREMS score.
详细描述
Background Trauma is the leading cause of death worldwide, particularly in those younger than 35 years of age. Injuries and violence represent a major global public health issue. According to the World Health Organization (WHO), injuries and violence cause approximately 4.4 million deaths worldwide each year, accounting for nearly 8% of all deaths. Of these, about 3.16 million deaths are attributable to unintentional injuries and 1.25 million to violence-related injuries. Injuries and violence also contribute substantially to disability, with an estimated 10% of all years lived with disability attributed to these conditions.
Trauma severity scoring systems are important adjuncts to trauma care and are used to characterize the nature and extent of injury. They can support triage and assist in assessing and predicting patient outcomes, thereby helping to organize and improve trauma care systems. Trauma scoring systems can be divided into anatomical, physiological, and combined scores, each with advantages and disadvantages. The combination of the anatomic scoring system and the physiological scoring system is better than a single scoring system for death prediction in patients with severe trauma in the ICU, and it may be considered to be a new method for early identification of death risk in patients with severe trauma.
The Rapid Emergency Medicine Score (REMS) is a physiological scoring system developed from the Acute Physiology and Chronic Health Evaluation II (APACHE II), which is considered a more rapid and less invasive version and is used for rapid risk stratification and prediction of mortality. It includes several parameters: age, mean arterial pressure, respiratory rate, pulse rate, peripheral oxygen saturation, and Glasgow Coma Scale (GCS). The modified REMS (mREMS) was subsequently developed specifically for trauma by substituting systolic blood pressure for mean arterial pressure, reducing the weighting of age, and increasing the weighting of GCS; in a large validation cohort, mREMS showed an AUROC of 0.967 for predicting in-hospital mortality.
The Glasgow Coma Scale (GCS) provides an objective method for assessing the level of impaired consciousness in patients with acute medical conditions or trauma and is one of the most widely used neurological assessment scales. It evaluates three components of responsiveness: eye-opening, verbal, and motor responses, with each component reported separately to provide a detailed description of neurological status. The individual scores can also be combined into a total GCS score, providing a concise indication of overall severity. The GCS is widely used in trauma, emergency, and critical care settings and supports clinical assessment, triage, monitoring, and communication among healthcare professionals.
The Glasgow Coma Scale (GCS) has several limitations that can affect its reliability and clinical interpretation. The verbal component cannot be assessed reliably in patients who are intubated, pharmacologically sedated, or unable to speak, resulting in missing GCS values and limiting the use of the total score for prognostic models. The Glasgow Coma Scale (GCS) is limited in its ability to evaluate patients with concomitant head and spinal cord injury. Also, a comatose patient receives a GCS score of 3, which coincidentally matches the Glasgow Coma Scale (GCS) assigned to a deceased individual. Drug and alcohol intoxication can interfere with GCS assessment in trauma patients. DiGiorgio et al. found that intoxicated patients had greater changes in Glasgow Coma Scale (GCS) assigned scores than patients without detected substances, suggesting that intoxication may contribute to an initially depressed or variable Glasgow Coma Scale (GCS) assigned. The authors therefore recommended considering and addressing intoxicants when interpreting GCS scores to improve the accuracy of assessment and benchmarking. Painful stimuli used in the Best Eye and Best Motor Response assessments can complicate scoring, especially in polytrauma patients with spinal cord injuries.
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 with sufficient clinical data to calculate the fREMS score, including the FOUR Score and other required physiological variables.
- •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 15 days through discharge)
Mortality (death) during hospitalization
次要结局
未报告次要终点
研究者
Abdulillah R. Khamees
Principal Investigator
Al-Nahrain University
