Evaluation of the Right Ventricular Systolic Function Using Real-time Three-dimensional Echocardiography in Intensive Care Unit Patients
- Conditions
- Lung DiseasesIntensive Care UnitsVentricular Dysfunction, Right
- Interventions
- Diagnostic Test: Real-time three-dimensional echocardiography
- Registration Number
- NCT04222764
- Lead Sponsor
- University Hospital, Limoges
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 341
-
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Real-time three-dimensional echocardiography Real-time three-dimensional echocardiography -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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%)
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
RVEF measurement through study completion, an average of 28 days RVEF measured using 3D TEE and 3D TTE (comparability if maximal difference \< 10%)
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
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)
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
Trial Locations
- Locations (2)
Limoges university hospital
🇫🇷Limoges, France
CHU de TOURS
🇫🇷Tours, France