Ignite Creation Date:
2024-05-06 @ 2:08 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04222764
Status:
COMPLETED
Last Update Posted:
2024-01-09
First Post:
2020-01-07
Brief Title:
Evaluation of the Right Ventricular Systolic Function Using Real-time Three-dimensional Echocardiography in Intensive Care Unit Patients
Sponsor:
University Hospital Limoges
Organization:
University Hospital Limoges
Study Overview
Official Title:
Evaluation of the Right Ventricular Systolic Function Using Real-time Three-dimensional Echocardiography in Intensive Care Unit Patients
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REA-3D-VD
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 ie 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None