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Clinical Trials/NCT04222764
NCT04222764
Completed
N/A

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

University Hospital, Limoges2 sites in 1 country341 target enrollmentApril 3, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Ventricular Dysfunction, Right
Sponsor
University Hospital, Limoges
Enrollment
341
Locations
2
Primary Endpoint
Echocardiographic parameter
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 3, 2020
End Date
September 28, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Limoges
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Echocardiographic parameter

Time Frame: 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 Outcomes

  • RV end-diastolic volume measurement(through study completion, an average of 28 days)
  • RV end-systolic volume measurement(through study completion, an average of 28 days)
  • Number of deceased participant(through study completion, an average of 28 days)
  • longitudinal systolic distortion of the RV free wall (strain) measurement(through study completion, an average of 28 days)
  • RVEF measurement(through study completion, an average of 28 days)
  • Percentage of performed measurement(through study completion, an average of 28 days)
  • Diagnosis of acute cor pulmonale(through study completion, an average of 28 days)
  • Threshold values of the conventional echocardiographic parameters identification(through study completion, an average of 28 days)
  • RVEF measurement 3D(through study completion, an average of 28 days)
  • Conventional echocardiographic parameters of RV systolic function measurement 3D(through study completion, an average of 28 days)

Study Sites (2)

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