Evaluation of the Right Ventricular Systolic Function Using Real-time Three-dimensional Echocardiography in Intensive Care Unit Patients (REA-3D-VD)

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Ventricular Dysfunction, Right; Intensive Care Units
• Intervention / Treatment: Diagnostic test: Real-time three-dimensional echocardiography

• Study Type: Observational
• Enrollment (Actual): 341

Contacts and Locations

• Study Contact: Name: EVRARD Bruno, MD; Phone Number: +33 555058841; Email: bruno.evrard@chu-limoges.fr
• Study Contact Backup: Name: BOURZEIX Paul; Phone Number: +33 555058841; Email: paul.bourzeix@chu-limoges.fr

Study Locations

• France
  • Limoges, France, 87042
    • Limoges university hospital
  • Tours, France
    • CHU de Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

high risk right ventricular Failure intensive care patients

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Real-time three-dimensional echocardiography

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Threshold values of the conventional echocardiographic parameters identification	Threshold values of the conventional echocardiographic parameters to identify RV systolic dysfunction identified with RVEF measurement using 3D TTE (ROC curves: best sensitivity/specificity compromise)	through study completion, an average of 28 days
RV end-diastolic volume measurement	RV end-diastolic measured using 3D TEE and 3D TTE (comparability if maximal difference < 10%)	through study completion, an average of 28 days
RV end-systolic volume measurement	RV end-systolic volume measured using 3D TEE and 3D TTE (comparability if maximal difference < 10%)	through study completion, an average of 28 days
RVEF measurement	RVEF measured using 3D TEE and 3D TTE (comparability if maximal difference < 10%)	through study completion, an average of 28 days
RVEF measurement 3D	RVEF measured using 3D echocardiography (reference) and conventional echocardiographic parameters of RV systolic function in each disease responsible for RVF	through study completion, an average of 28 days
Conventional echocardiographic parameters of RV systolic function measurement 3D	Conventional echocardiographic parameters of RV systolic function measured using 3D echocardiography in each disease responsible for RVF	through study completion, an average of 28 days
Percentage of performed measurement	Percentage of performed measurements correlated to the theoretical number of possible measurements; intra and inter-observer reproducibility	through study completion, an average of 28 days
Diagnosis of acute cor pulmonale	Agreement between conventional echocardiography and 3D echocardiography for the diagnosis of acute cor pulmonale (most severe type of RVF) as defined by an acute RV dilatation (RV/Left Ventricular end-diastolic area ratio > 0.6 in the long-axis view of the heart) associated to a paradoxical septum in the short-axis view of the heart	through study completion, an average of 28 days
Number of deceased participant	ICU and hospital mortality	through study completion, an average of 28 days
longitudinal systolic distortion of the RV free wall (strain) measurement	Relation and agreement between longitudinal systolic distortion of the RV free wall (strain), RVEF, and conventional parameters of RV systolic function	through study completion, an average of 28 days

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2020
• Primary Completion (Actual): September 28, 2023
• Study Completion (Actual): September 28, 2023

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Lung Diseases; Intensive Care Units; Right ventricular failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Right
• Other Study ID Numbers: 87RI19_0035 (REA-3D-VD)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No