Evaluation of the Right Ventricular Systolic Function Using Real-time Three-dimensional Echocardiography in Intensive Care Unit Patients

Lung Diseases Clinical Trial

— REA-3D-VD  

Official title:

Evaluation of the Right Ventricular Systolic Function Using Real-time Three-dimensional Echocardiography in Intensive Care Unit Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04222764
• Other study ID #: 87RI19_0035 (REA-3D-VD)
• Status: Completed
• Start date: April 3, 2020
• Est. completion date: September 28, 2023

Study information

• Verified date: January 2024
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Right ventricular failure (RVF) is an independent factor of mortality for many pulmonary diseases. Currently, RVF is defined as the incapacity of the RV to maintain the flow without dilating to use the Frank-Starling law (i.e., increase of the ejection volume associated to an increase of the preload). RVF is associated to RV systolic dysfunction which is conventionally defined as a decrease of the RV ejection fraction (RVEF) < 45%. In the intensive care unit (ICU), acute RVF is mainly due to the acute respiratory distress syndrome (ARDS), sepsis or septic shock, and less often to severe pulmonary embolism or RV infarction. The anatomical complexity of the RV precludes any geometrical assumption to estimate its volume, hence its ejection fraction (EF) using two-dimensional (2D) echocardiography. For this reason, the evaluation of RV systolic function is currently based on parameters used as surrogates of RVEF: fraction area change in 2D-mode, tricuspid annular plane systolic excursion (TAPSE) in M-mode, and maximal velocity of the systolic S' wave using tissue Doppler imaging. Real-time three-dimensional (3D) echocardiography now enables accurate on-line measurement of RV volume and provides at the bedside the non-invasive assessment of RVEF. 3D transthoracic echocardiography (TTE) has been validated to measure RV volume and RVEF compared to MRI which is the gold standard. However, 3D transesophageal echocardiography (TEE) has not yet been validated in this specific clinical setting, while 2D TEE is frequently used in ICU in ventilated and sedated patients. Accordingly, the diagnostic ability of 3D echocardiography to quantify RV systolic function in ICU patients with RVF of any origin is currently unknown.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: September 28, 2023
• Est. primary completion date: September 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients (= 18 years old) hospitalized in the ICU and requiring echocardiography for any reason

2. With a disease at risk of being associated with RVF:

• ARDS (Berlin definition)
• Sepsis or septic shock (Sepsis-3 definition)
• Pulmonary embolism
• RV infarction

3. Affiliated to Social Security

4. Consent of the patient and/or his authorized representative to participate in the study.

Exclusion Criteria:

1. History of congenital cardiac disease

2. Patient under legal protection

3. Under any method of oxygen support or extracorporeal circulatory support (veno-venous extracorporeal membrane oxygenation, extracorporeal Life support...)

4. Non sinusal rhythm

5. Documented preexisting right cardiac disease

6. Quality of echocardiographic images incompatible with 3D assessment.

Related Conditions & MeSH terms

• Intensive Care Units
• Lung Diseases
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

Diagnostic Test:
• Real-time three-dimensional echocardiography
The initial hemodynamic assessment and monitoring using echocardiography will be performed within 12h following ICU admission. TTE will be performed systematically as first-line examination and TEE will be performed only on ventilated and sedated patients for whom additional information is required for their management, according to the standards of care of the participating centers. In that case, TEE will be performed immediately after TTE. 3D echocardiographic measurements will be performed after the examination by two independent intensivists expert in critical care echocardiography who will be blinded from the usual parameters of RV systolic functions; these parameters will be measured during the examination to guide the management of patients, according to the standard of care of the participating centers.

Locations

Country	Name	City	State
France	Limoges university hospital	Limoges
France	CHU de TOURS	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Echocardiographic parameter	Agreement between the values of conventional echocardiographic parameters of RV systolic function and RVEF measured using TTE and considered as reference	through study completion, an average of 28 days
Secondary	Threshold values of the conventional echocardiographic parameters identification	Threshold values of the conventional echocardiographic parameters to identify RV systolic dysfunction identified with RVEF measurement using 3D TTE (ROC curves: best sensitivity/specificity compromise)	through study completion, an average of 28 days
Secondary	RV end-diastolic volume measurement	RV end-diastolic measured using 3D TEE and 3D TTE (comparability if maximal difference < 10%)	through study completion, an average of 28 days
Secondary	RV end-systolic volume measurement	RV end-systolic volume measured using 3D TEE and 3D TTE (comparability if maximal difference < 10%)	through study completion, an average of 28 days
Secondary	RVEF measurement	RVEF measured using 3D TEE and 3D TTE (comparability if maximal difference < 10%)	through study completion, an average of 28 days
Secondary	RVEF measurement 3D	RVEF measured using 3D echocardiography (reference) and conventional echocardiographic parameters of RV systolic function in each disease responsible for RVF	through study completion, an average of 28 days
Secondary	Conventional echocardiographic parameters of RV systolic function measurement 3D	Conventional echocardiographic parameters of RV systolic function measured using 3D echocardiography in each disease responsible for RVF	through study completion, an average of 28 days
Secondary	Percentage of performed measurement	Percentage of performed measurements correlated to the theoretical number of possible measurements; intra and inter-observer reproducibility	through study completion, an average of 28 days
Secondary	Diagnosis of acute cor pulmonale	Agreement between conventional echocardiography and 3D echocardiography for the diagnosis of acute cor pulmonale (most severe type of RVF) as defined by an acute RV dilatation (RV/Left Ventricular end-diastolic area ratio > 0.6 in the long-axis view of the heart) associated to a paradoxical septum in the short-axis view of the heart	through study completion, an average of 28 days
Secondary	Number of deceased participant	ICU and hospital mortality	through study completion, an average of 28 days
Secondary	longitudinal systolic distortion of the RV free wall (strain) measurement	Relation and agreement between longitudinal systolic distortion of the RV free wall (strain), RVEF, and conventional parameters of RV systolic function	through study completion, an average of 28 days