Clinical trial NCT04222764: Evaluation of the Right Ventricular Systolic Function Using Real-time Three-dimensional Echocardiography in Intensive Care Unit Patients
Official title: Evaluation of the Right Ventricular Systolic Function Using Real-time Three-dimensional Echocardiography in Intensive Care Unit Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Dysfunction, Right
Lung Diseases
Intensive Care Units
Keywords: Right ventricular failure
Lung Diseases
Intensive Care Units
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 341
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: high risk right ventricular Failure intensive care patients

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Echocardiographic parameter
timeFrame: through study completion, an average of 28 days
Secondary outcomes:
measure: Threshold values of the conventional echocardiographic parameters identification
timeFrame: through study completion, an average of 28 days
measure: RV end-diastolic volume measurement
timeFrame: through study completion, an average of 28 days
measure: RV end-systolic volume measurement
timeFrame: through study completion, an average of 28 days
measure: RVEF measurement
timeFrame: through study completion, an average of 28 days
measure: RVEF measurement 3D
timeFrame: through study completion, an average of 28 days
measure: Conventional echocardiographic parameters of RV systolic function measurement 3D
timeFrame: through study completion, an average of 28 days
measure: Percentage of performed measurement
timeFrame: through study completion, an average of 28 days
measure: Diagnosis of acute cor pulmonale
timeFrame: through study completion, an average of 28 days
measure: Number of deceased participant
timeFrame: through study completion, an average of 28 days
measure: longitudinal systolic distortion of the RV free wall (strain) measurement
timeFrame: through study completion, an average of 28 days
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges university hospital
city: Tours
country: France
facility: CHU de TOURS
Study officials:
References: