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Evaluation of Three Trauma Mortality Scores in Adults Admitted to Intensive Care in Tunisia (TICU-SCORES)

2026年9月29日 更新者：Sameh Ben Ahmed、University Tunis El Manar

External Validation and Local Recalibration of GAP, MGAP, and the New Trauma Score for Triage (T-NTS) for All-Cause In-Hospital Mortality in Adult Trauma Patients Admitted to Intensive Care in Tunisia: A Retrospective Cohort Study

The goal of this retrospective observational study is to learn how well three simple trauma scores predict death during the hospital stay in adults admitted to intensive care after an injury in Tunisia. The scores are the Glasgow Coma Scale, Age, and Systolic Blood Pressure score (GAP); the Mechanism, Glasgow Coma Scale, Age, and Systolic Blood Pressure score (MGAP); and the New Trauma Score for Triage (T-NTS). Researchers will review existing medical records for admissions from 1 January 2018 through 31 December 2025. They will not assign treatment or contact participants. The main question is how accurately the three scores distinguish participants who died in the hospital from those discharged alive. Secondary analyses will examine agreement between score-based risk and observed mortality and performance for mortality by day 7 after ICU admission.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This single-centre retrospective cohort study will externally validate GAP, MGAP, and T-NTS in an ICU-selected adult trauma population at a tertiary hospital in Tunisia. All consecutive eligible adults physically admitted to the participating ICU during the fixed eight-year clinical window will be screened. Predictor values will be taken from the earliest qualified assessment after injury and before sedation, neuromuscular blockade, and tracheal intubation. The study therefore evaluates prognosis among trauma patients who reached intensive care and does not claim validation for triage of all emergency-department trauma patients.

The primary endpoint is death from any cause before live discharge from the continuous index admission to the study hospital. The primary comparison will use one common complete-case cohort with known outcome, age, mechanism, qualified Glasgow Coma Scale, systolic blood pressure, and peripheral oxygen saturation. Missing predictor values will not be imputed and will not change cohort eligibility; missingness and the flow from screened to eligible and analyzable participants will be reported.

Score discrimination will be summarized by area under the receiver operating characteristic curve with 95% confidence intervals and paired comparisons using DeLong's method. Observed mortality will be described within original score risk groups. Separate one-predictor logistic models will estimate local score-to-risk relationships, with 1,000 bootstrap resamples for internal validation. Mortality by calendar day 7 after index ICU admission will be a prespecified secondary endpoint if retained in the final signed protocol. No treatment, diagnostic procedure, or exposure is assigned by the investigators.

研究类型

观察性的

注册 (估计的)

1000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Adults aged 18 years or older who were physically admitted to the intensive care unit of Mohamed Tahar Maâmouri Hospital, Nabeul, Tunisia, because acute blunt or penetrating trauma, or an immediate consequence of that trauma, was the principal indication for critical care between 1 January 2018 and 31 December 2025. All consecutive potentially eligible admissions will be identified from the ICU registers and medical records. Only the first qualifying trauma episode and ICU admission per patient will be included. Eligible patients with missing score variables will remain in the eligible cohort but may not enter the common complete-case analysis

描述

Inclusion Criteria:

  1. Age 18 years or older at the earliest qualified assessment.
  2. Acute physical injury caused by a blunt or penetrating mechanism.
  3. Trauma or an immediate consequence of trauma was the principal reason for the first qualifying intensive care unit admission.
  4. The first qualifying intensive care unit admission occurred from 1 January 2018 through 31 December 2025, inclusive.
  5. The intensive care unit admission belonged to the continuous acute hospitalization following the index injury.

Exclusion Criteria:

  1. Age younger than 18 years.
  2. No physical admission to the participating intensive care unit, including death before ICU admission.
  3. Isolated burn, isolated inhalation injury, drowning, hanging, asphyxia, poisoning, or isolated thermal, electrical, or chemical injury without qualifying blunt or penetrating trauma.
  4. ICU admission for a medical condition when trauma was incidental and not the principal indication for critical care.
  5. Elective, reconstructive, rehabilitation, or late readmission after discharge from the acute trauma hospitalization.
  6. Iatrogenic injury or procedural complication without qualifying external blunt or penetrating trauma.
  7. Duplicate record or ICU readmission within the same trauma hospitalization.
  8. A later eligible trauma episode in a patient already included during the study period.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：RETROSPECTIVE

队列和干预

团体/队列
干预/治疗
Adult Trauma ICU Cohort

All consecutive eligible adults admitted to the participating intensive care unit because of acute blunt or penetrating trauma between 1 January 2018 and 31 December 2025. GAP, MGAP, and the New Trauma Score for Triage (T-NTS) will be calculated retrospectively from routinely recorded clinical data. No treatment or diagnostic procedure is assigned by the investigators.
其他：Trauma mortality prediction scores: GAP, MGAP, and T-NTS

The Glasgow Coma Scale, Age, and Systolic Blood Pressure score (GAP); the Mechanism, Glasgow Coma Scale, Age, and Systolic Blood Pressure score (MGAP); and the New Trauma Score for Triage (T-NTS) will be calculated retrospectively using existing clinical information recorded before sedation, neuromuscular blockade, or tracheal intubation whenever available. The scores are evaluated as prognostic tools; they are not used to assign treatment or alter patient care.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Discrimination of GAP, MGAP, and T-NTS for All-Cause In-Hospital Mortality
大体时间：From index hospital presentation to in-hospital death or live discharge during the continuous index hospitalization (expected up to 12 months)

The clinical endpoint is death from any cause before live discharge from the continuous index admission to the study hospital. For each score, discrimination will be quantified by the area under the receiver operating characteristic curve (AUROC) with a 95% confidence interval in the common complete-case cohort. AUROC ranges from 0.5 (no discrimination) to 1.0 (perfect discrimination). Correlated AUROCs will be compared using DeLong's method.
From index hospital presentation to in-hospital death or live discharge during the continuous index hospitalization (expected up to 12 months)

次要结果测量

结果测量
措施说明
大体时间
Calibration and Local Recalibration of GAP, MGAP, and T-NTS for All-Cause In-Hospital Mortality
大体时间：From index hospital presentation to in-hospital death or live discharge during the continuous index hospitalization (expected up to 12 months)

Observed all-cause in-hospital mortality with 95% confidence intervals will be reported within the original risk groups of each score. For each score, a one-predictor logistic model relating the original total score to mortality will estimate a local score-to-risk relationship. Internal validation of the recalibration procedure will use 1,000 bootstrap resamples.
From index hospital presentation to in-hospital death or live discharge during the continuous index hospitalization (expected up to 12 months)
Discrimination of GAP, MGAP, and T-NTS for All-Cause In-Hospital Mortality by Day 7
大体时间：From index ICU admission through calendar day 7 (ICU admission date = day 0)

The clinical endpoint is death from any cause in the study hospital on or before calendar day 7 after the first qualifying ICU admission; the ICU admission date is day 0. The endpoint is derived from dates and is not an exact 168-hour measure. Discrimination of GAP, MGAP, and T-NTS will be summarized by AUROC with 95% confidence intervals; paired DeLong comparisons will be reported if the number of day-7 deaths is adequate.
From index ICU admission through calendar day 7 (ICU admission date = day 0)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Tunis El Manar

调查人员

  • 首席研究员：sameh ben ahmed, MD、Anesthesiology and Intensive Care Unit, Mohamed Taher Maamouri Teaching Hospital Faculty of Medicine of Tunis, University Tunis El Manar Mrezga, 8000 Nabeul, Tunisia

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2026年12月15日

研究完成 (估计的)

2026年12月15日

研究注册日期

首次提交

2026年9月23日

首先提交符合 QC 标准的

2026年9月23日

首次发布 (实际的)

2026年9月30日

研究记录更新

最后更新发布 (实际的)

2026年10月2日

上次提交的符合 QC 标准的更新

2026年9月29日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HTMM-TICU-SCORES-01
  • 59-2026 (其他标识符：Comité d'éthique de l'Hôpital Mohamed Tahar Maâmouri)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant-level data extracted from confidential medical records will not be made publicly available. The data dictionary and statistical code may be shared with publication subject to ethics and institutional approval

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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