跳至主要内容
临床试验/NCT04748003
NCT04748003已完成不适用

Assessment of Prevalence and Prognostic Value of Acute Myocardial Dysfunction in Severe Trauma Patients With Chest Trauma Using 2D-strain Ultrasound: A Prospective Observational Study

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Occurrence of an a segmental or global acute myocardial dysfunction

研究概览

简要总结

This study aims to investigate whether the identification of acute myocardial dysfunction by 2D-strain transthoracic sonography in the first week following trauma would allow to better diagnose occult and severe patterns of myocardial contusion, in order to identify a subpopulation at higher risk of complications.

The measurement of myocardial strain (2D-strain) by transthoracic sonography is a robust tool to assess the myocardial function.

The investigators strongly suppose that the 2D-strain would allow to better identify subclinical MC in chest trauma, as well as the severe patterns that are associated with more organs dysfunctions and a worst outcome.

详细描述

Thoracic trauma is the cause of significant morbidity and accounts for 25% of trauma-related deaths.

The myocardial contusion (MC) is a distinct injury, which has a prevalence increasing with the severity of the trauma. The diagnostic tool is a major factor to vary the prevalence of MC (i.e. clinical exam, biology, electrocardiogram), with the highest values for autopsy series, until 24% of patients. It does not exist therefore of gold standard for the diagnosis of MC in clinical practice leading to a modest knowledge of this nosological entity. In clinical practice, troponin plasma level determines the diagnostic.

Otherwise, the measurement of myocardial strain (2D-strain) by transthoracic echocardiography (TTE) is a robust tool to assess the myocardial function. This ultrasound analysis allows an objective and topographical quantification of an acute myocardial dysfunction, be it global or segmental. 2D-strain has been thus has been validated for the diagnosis of myocardial dysfunction in medical setting. Its use in trauma setting has never been reported.

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 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • severe trauma patients with blunt chest trauma
  • (AIS Thorax score ≥ 1)
  • admitted in our trauma intensive care unit
  • and included within the 24 first hours following trauma

排除标准

  • Imminent death
  • Recovered cardiocirculatory arrest following trauma
  • Critical patient : AIS score ≥5 on 1 lesion, requiring ECLS (extracorporeal life support) or REBOA (resuscitative endovascular balloon occlusion of the aorta)
  • Refractory hypovolaemia
  • Arrhythmia, atrial fibrillation
  • Congenital heart disease, ischemic cardiomyopathy, moderate or severe pre-existing valvular heart disease, pulmonary arterial hypertension (PAH)
  • Valve prosthesis or pacemaker
  • Insufficient quality of ultrasound image to allow correct assessment of 2D-strain
  • Pregnant woman and underage patients

结局指标

主要结局

Occurrence of an a segmental or global acute myocardial dysfunction

时间窗: In the first week following trauma

Using transthoracic echocardiography to assess the myocardial function

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验