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Completed

NCT Number: NCT04222764

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

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.

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Key information

Conditions

Ventricular Dysfunction, Right Cardiovascular Diseases Heart Diseases Heart Failure Intensive Care Units Lung Diseases Respiratory Tract Diseases Ventricular Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Limoges university hospital, Limoges, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Threshold values of the conventional echocardiographic parameters identification

    Time frame: through study completion, an average of 28 days

    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)

  2. RV end-diastolic volume measurement

    Time frame: through study completion, an average of 28 days

    RV end-diastolic measured using 3D TEE and 3D TTE (comparability if maximal difference < 10%)

  3. RV end-systolic volume measurement

    Time frame: through study completion, an average of 28 days

    RV end-systolic volume measured using 3D TEE and 3D TTE (comparability if maximal difference < 10%)

  4. RVEF measurement

    Time frame: through study completion, an average of 28 days

    RVEF measured using 3D TEE and 3D TTE (comparability if maximal difference < 10%)

  5. RVEF measurement 3D

    Time frame: through study completion, an average of 28 days

    RVEF measured using 3D echocardiography (reference) and conventional echocardiographic parameters of RV systolic function in each disease responsible for RVF

  6. Conventional echocardiographic parameters of RV systolic function measurement 3D

    Time frame: through study completion, an average of 28 days

    Conventional echocardiographic parameters of RV systolic function measured using 3D echocardiography in each disease responsible for RVF

  7. Percentage of performed measurement

    Time frame: through study completion, an average of 28 days

    Percentage of performed measurements correlated to the theoretical number of possible measurements; intra and inter-observer reproducibility

  8. Diagnosis of acute cor pulmonale

    Time frame: through study completion, an average of 28 days

    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

  9. Number of deceased participant

    Time frame: through study completion, an average of 28 days

    ICU and hospital mortality

  10. longitudinal systolic distortion of the RV free wall (strain) measurement

    Time frame: through study completion, an average of 28 days

    Relation and agreement between longitudinal systolic distortion of the RV free wall (strain), RVEF, and conventional parameters of RV systolic function

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: REA-3D-VD

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2020
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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