Acute Myocardial Dysfunction and Chest Trauma - The Strainy Trauma Study

Chest Trauma Clinical Trial

— Strainy trauma  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04748003
• Other study ID #: RECHMPL20_0380
• Status: Completed
• Start date: February 28, 2021
• Est. completion date: February 28, 2021

Study information

• Verified date: March 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chest Trauma
• Thoracic Injuries
• Wounds and Injuries

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier	Montepllier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of an a segmental or global acute myocardial dysfunction	Using transthoracic echocardiography to assess the myocardial function	In the first week following trauma