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

NCT04222764 | Completed

• 1 other identifier: 87RI19_0035 (REA-3D-VD)
• Study Type: observational
• Target: 341
• Locations: 1 country
• Sites: 2

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.

Conditions

Ventricular Dysfunction, Right; Lung Diseases; Intensive Care Units

Keywords

Right ventricular failure; Lung Diseases; Intensive Care Units

Outcome Measures

Primary Outcomes (1)

• Echocardiographic parameter

  Agreement between the values of conventional echocardiographic parameters of RV systolic function and RVEF measured using TTE and considered as reference

  through study completion, an average of 28 days

Secondary Outcomes (10)

• Threshold values of the conventional echocardiographic parameters identification

  through study completion, an average of 28 days

• 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

• RVEF measurement

  through study completion, an average of 28 days

• RVEF measurement 3D

  through study completion, an average of 28 days

Study Arms (1)

Real-time three-dimensional echocardiography

Diagnostic Test: Real-time three-dimensional echocardiography

Interventions

Real-time three-dimensional echocardiography DIAGNOSTIC_TEST

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.

Real-time three-dimensional echocardiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

high risk right ventricular Failure intensive care patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (2)

Limoges university hospital

Limoges, 87042, France

Location

CHU de TOURS

Tours, France

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Right; Lung Diseases; Heart Failure

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 10, 2020
• Study Start: April 3, 2020
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Locations

FR (2)