NCT04222764

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 341 (actual)
• Sponsor: University Hospital, Limoges · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-04-03
• Primary completion: 2023-09-28
• Completion: 2023-09-28
• First posted: 2020-01-10
• Last updated: 2024-01-09

Locations

2 sites across 1 country: France