Comparison Between a Robotic Tele-echo-cardiography Technique and a Standard Echocardiography in the Management of Heart Failure in the Guadeloupe Archipelago Between the University Hospital of Guadeloupe and the Marie-Galante Hospital (TER de blueS)

Centre Hospitalier Universitaire de la Guadeloupe

Status: Enrolling

Conditions: Remote Consultation, Teleconsultation; Echocardiography, Doppler; Heart Failure

Treatments: Diagnostic Test: two-dimensional remote echocardiography (TER); Diagnostic Test: in situ echocardiography (EIS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07265986

PAP_RI2_2019/02

Details and patient eligibility

About

The TERdeblue-S study is a feasibility study of robotic remote echocardiography, not only in terms of technology but also in terms of its integration into a telemedicine system to improve access to the heart failure management system in the Guadeloupe archipelago. The main objective of this study is to study the agreement of the measurement of the left ventricular ejection fraction (FejVG) between in situ echocardiography (EIS) and two-dimensional remote echocardiography (TER) (distance and volumes).

Full description

Considered as the new global epidemic of the 21st century, heart failure (HF) is a major public health issue. In 2010, the Guadeloupe region already had the highest rate of heart failure deaths in all French departments, furthermore cardiac decompensation of chronic heart failure is the first cardiovascular pathology to be managed in emergency medicine and the first cardiovascular cause of hospitalization. Marie-Galante is an island in the Guadeloupe archipelago, 36% of whose hospital stays are covered by the University Hospital Currently, access to specialized care in Marie-Galante, particularly cardiological care, is very limited with one to two monthly consultations by a specialist cardiologist accessible to a population . Rather, remote echocardiography has been the subject of experimental studies but has not yet been proposed as part of an optimization of the management of a specific cardiovascular disease at separate sites. This is a prospective multicentre study (two cardiologists in private practice of Guadeloupe and one at the Marie-Galante Hospital) interventional cross-over study in which the left ventricular ejection fraction (LVEF) will be the main judgement criterion. Patients will be randomized to determine the order of implementation of the techniques (echocardiography and then teleecardiography or the reverse). In addition, in order to take into account the operator effect, each of the 2 cardiologists will move alternately either for remote echocardiography or to Marie-Galante for in situ echocardiography.

The visit (V1) takes place at Marie-Galante's CH, as soon as possible after inclusion by the generalist practicionner or the cardiologist (V0) and is carried out by the state-registered nurse with a blood sample (biological check-up and biological collection) and ECG Holter place over 24 hours.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years

  • Free, informed and written consent signed by the participant and the investigator
  • Person affiliated or benefiting from a social security scheme.
  • Patient meeting at least one of the following criteria:

• Systematic cardiovascular check-up or asymptomatic patient with cardiovascular risk factor (hypertension, diabetes, obesity, tobacco, alcohol)

• Clinical suspicion of heart disease and/or chronic heart failure with stability of at least one week.

  • Family history of heart disease and/or sudden death

Exclusion criteria

• Patient requiring urgent cardiological management with transfer to the University Hospital

  • Acute unstable heart failure, admission to CH Marie-Galante less than 5 days (less than one week)
  • Pregnant women

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Arm A: in situ ultrasound (EIS) performed first

Experimental group

Description:

The in situ ultrasound (EIS) is performed first. Cardiologist A performs the imaging examination and then leaves the room. The Research Nurse installs the probe and then cardiologist B, positioned on the expert site in Guadeloupe, carries out the examination of robotic tele-echo-cardiography (TER). Cardiologist B communicates via videoconferencing with the patient and the Research Nurse.

Treatment:

Diagnostic Test: in situ echocardiography (EIS)

Diagnostic Test: two-dimensional remote echocardiography (TER)

Arm B: two-dimensional remote echocardiography (TER) performed first

Experimental group

Description:

The TER is carried out first. The probe is installed by the REsearch Nurse, cardiologist B positioned on the expert site of Guadeloupê carries out the TER examination. Cardiologist B communicates via videoconferencing with the patient and the remote assistant EDI. Then, once the examination is completed, cardiologist A performs the HIA.

Treatment:

Diagnostic Test: in situ echocardiography (EIS)

Diagnostic Test: two-dimensional remote echocardiography (TER)