REA-3D-VD: Evaluation of the Right Ventricular Systolic Function Using Real-time Three-dimensional Echocardiography in Intensive Care Unit Patients

Sponsor

University Hospital, Limoges (Other)

Overall Status

Recruiting

CT.gov ID

NCT04222764

Collaborator

(none)

308

Enrollment

Locations

Anticipated Duration (Months)

154

Patients Per Site

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Dysfunction, Right Lung Diseases Intensive Care Units	Diagnostic Test: Real-time three-dimensional echocardiography

Study Design

Study Type:

Observational

Anticipated Enrollment :

308 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 3, 2020

Anticipated Primary Completion Date :

Dec 3, 2023

Anticipated Study Completion Date :

Dec 3, 2023

Arms and Interventions

Arm	Intervention/Treatment
Real-time three-dimensional echocardiography	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.

Arm

Intervention/Treatment

Real-time three-dimensional echocardiography

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.

Outcome Measures

Primary Outcome Measures

Echocardiographic parameter [through study completion, an average of 28 days]
Agreement between the values of conventional echocardiographic parameters of RV systolic function and RVEF measured using TTE and considered as reference

Secondary Outcome Measures

Threshold values of the conventional echocardiographic parameters identification [through study completion, an average of 28 days]
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)
RV end-diastolic volume measurement [through study completion, an average of 28 days]
RV end-diastolic measured using 3D TEE and 3D TTE (comparability if maximal difference < 10%)
RV end-systolic volume measurement [through study completion, an average of 28 days]
RV end-systolic volume measured using 3D TEE and 3D TTE (comparability if maximal difference < 10%)
RVEF measurement [through study completion, an average of 28 days]
RVEF measured using 3D TEE and 3D TTE (comparability if maximal difference < 10%)
RVEF measurement 3D [through study completion, an average of 28 days]
RVEF measured using 3D echocardiography (reference) and conventional echocardiographic parameters of RV systolic function in each disease responsible for RVF
Conventional echocardiographic parameters of RV systolic function measurement 3D [through study completion, an average of 28 days]
Conventional echocardiographic parameters of RV systolic function measured using 3D echocardiography in each disease responsible for RVF
Percentage of performed measurement [through study completion, an average of 28 days]
Percentage of performed measurements correlated to the theoretical number of possible measurements; intra and inter-observer reproducibility
Diagnosis of acute cor pulmonale [through study completion, an average of 28 days]
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
Number of deceased participant [through study completion, an average of 28 days]
ICU and hospital mortality
longitudinal systolic distortion of the RV free wall (strain) measurement [through study completion, an average of 28 days]
Relation and agreement between longitudinal systolic distortion of the RV free wall (strain), RVEF, and conventional parameters of RV systolic function

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patients (≥ 18 years old) hospitalized in the ICU and requiring echocardiography for any reason
With a disease at risk of being associated with RVF:

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

Affiliated to Social Security
Consent of the patient and/or his authorized representative to participate in the study.

Exclusion Criteria:

History of congenital cardiac disease
Patient under legal protection
Under any method of oxygen support or extracorporeal circulatory support (veno-venous extracorporeal membrane oxygenation, extracorporeal Life support...)
Non sinusal rhythm
Documented preexisting right cardiac disease
Quality of echocardiographic images incompatible with 3D assessment.