跳至主要内容
临床试验/NCT06711276
NCT06711276招募中不适用

A Prospective Evaluation of the New Injury Severity Score's Accuracy in Blunt Trauma Patients

Al-Nahrain University1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2025年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
210
试验地点
1
主要终点
In hospital mortality

研究概览

简要总结

The goal of this prospective observational study is to evaluate the predictive utility of the New Injury Severity Score (NISS) in determining mortality outcomes among blunt trauma patients admitted to the Emergency Department of Kadhimiya Educational Hospital, Iraq.

The main questions it aims to answer are:

How accurately does NISS predict mortality in blunt trauma patients? What is the performance of NISS in predicting secondary outcomes, such as the need for intensive care and length of hospital stay?

Participants will:

Be assessed using the NISS score upon their admission to the emergency department.

Have their clinical outcomes, including mortality, need for intensive care, and hospital stay, monitored throughout their hospitalization.

详细描述

Trauma is the leading cause of death among individuals under 45 years of age, who represent the most productive population of society. According to the World Health Organization, trauma will remain a major driver of years of productive life lost by the end of this decade. Blunt trauma, a common form of injury, typically results in solid organ damage rather than hollow organ injuries.

Trauma management protocols play a vital role in reducing mortality. For example, standardized resuscitation protocols have been shown to decrease mortality by 15% in severely injured patients. The Airway, Breathing, Circulation, Disability, Exposure (ABCDE) approach is a clinically proven framework for managing trauma patients, improving patient outcomes, optimizing team performance, and saving time during life-threatening emergencies. In addition to standardized protocols, scoring systems play a critical role in evaluating the severity of trauma and predicting patient outcomes.

The Injury Severity Score (ISS), introduced in 1974, is one of the most widely used anatomical scoring systems. It evaluates the severity of injuries by dividing the body into six regions: head and neck, face, thorax, abdomen, extremities (including pelvis), and external. Each injury is assigned a score using the Abbreviated Injury Scale (AIS), but only the highest AIS score from each region is used. The ISS is then calculated as the sum of the squares of the top three AIS scores, with a maximum value of 75. Patients with an AIS score of 6 in any region are automatically assigned the maximum ISS score.

However, ISS has limitations. By considering only the most severe injury per body region, which may underestimate the severity of trauma in patients with multiple injuries in the same region. To address this, Osler et al. developed the New Injury Severity Score (NISS) in 1997. Unlike ISS, NISS accounts for the total of squares of the three most severe injuries, regardless of their location in the body, providing a more comprehensive assessment of trauma severity. Studies have shown that NISS often results in higher scores compared to ISS, offering better predictions of patient outcomes in multiple trauma cases.

In addition to anatomical scoring systems like ISS and NISS, physiological scoring systems have been developed to predict outcomes in trauma patients. The Revised Trauma Score (RTS) evaluates physiological parameters, incorporating the Glasgow Coma Scale, systolic blood pressure, and respiratory rate to assess trauma severity and predict mortality.

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

  • Trauma patients admitted to the emergency department, presenting with blunt trauma, such as from motor vehicle accidents, falls, or assaults.
  • Patients with adequate documentation of anatomical injuries and physiological parameters required for NISS calculation.
  • Injury assessment and NISS calculation completed within the first 6 hours of arrival to ensure accuracy and consistency in trauma evaluation.

排除标准

  • Patients under 18 years, pregnant women, or those with pre-existing medical conditions that may alter trauma scoring accuracy or management outcomes.
  • Patients presenting with medical emergencies, terminal illnesses, or conditions unrelated to blunt trauma to ensure focus on trauma-specific evaluations.
  • Patients declared dead on arrival or who do not receive active treatment in the emergency department.
  • Patients or their families refusing participation or withdrawing consent at any stage of the study.
  • Patients transferred from or to another facility or those previously treated elsewhere, as this may affect data collection and scoring reliability.

结局指标

主要结局

In hospital mortality

时间窗: In-Hospital Phase (average of 6 days through discharge); Post-Discharge Follow-Up: Day 7, Day 30

Mortality (death) during hospitalization.

Accuracy Assessment of the New Injury Severity Score (NISS)

时间窗: the first 6 hours after ER admission

Range:0 to 75, with higher scores indicating worse outcomes and greater injury severity.

次要结局

  • Length of Hospitalization(Up to discharge, an average of 6 days)
  • Number of Participants Requiring ICU Admission(Up to discharge, an average of 6 days)
  • The Number of Participants Who Require Surgical Intervention(Up to discharge, an average of 6 days)

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

Abdul-Ilah R. Khamis

Principal Investigator

Al-Nahrain University

研究点 (1)

Loading locations...

相似试验