Clinical trial NCT04748003: Acute Myocardial Dysfunction and Chest Trauma - The Strainy Trauma Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Trauma
Keywords: Severe trauma
chest trauma
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Assistance Publique Hopitaux De Marseille
First posted: 2021-02-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe trauma patients with blunt chest trauma

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of an a segmental or global acute myocardial dysfunction
timeFrame: In the first week following trauma
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
state: Montepllier
Study officials:
affiliation: University Hospital, Montpellier
name: Jonathan CHARBIT, MD
role: PRINCIPAL_INVESTIGATOR
References: