HeartGuide: Preliminary Study

Not Applicable

Recruiting

• Conditions: Cardiac Disease
• Interventions: Other: recording of the probe position

• Registration Number: NCT05490303
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

Echocardiography is the examination of choice for the study of cardiac pathologies. Interest of echocardiography for other medical specialties has already been demonstrated (intensive care in the case of hemodynamic failure - in intra and extra hospital emergency medicine for the initial assessment of chest pain or dyspnea).

The expansion of echocardiography'use has been catalyzed by miniaturization of echographic systems and decrease in their price. Recently, probes directly connected to a tablet or phone have been developed at a limited cost.

Therefore, it's possible to consider these ultrasound scanners as the new stethoscope that could be used by any health professional.

The last limit to this democratization is the training, especially for non-specialists (non-cardiologists).

Detailed Description

Since January 2019, echocardiography laboratory headed by Prof. Stéphane Lafitte and DESKi (start-up - Bordeaux) have been working on guiding non-experts through their cardiac ultrasound examination.

An algorithm indicating in real time if the view obtained corresponds to a reference view has already been validated. However, this algorithm does not tell the operator which movement would improve the image quality.

Thanks to advances in deep learning and by combining cardiac ultrasound acquisitions with systems that record the position of the probes in real time, it would be possible to develop an algorithm able to guide the operator's movements.

Study Timeline

• Study First Submitted: 2022-07-29
• Study First Submitted QC: 2022-08-03
• Study First Posted: 2022-08-05
• Study Start: 2022-09-09
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-14
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients (male or female) older than 18 years,
• Patient having a scheduled cardiac ultrasound outside any emergency context,
• Patients who have not objected to participating in the research (at the latest on the day of inclusion and before any examination required by the research),
• Subjects affiliated or benefiting from a social security plan,
• Women of childbearing age who are using effective contraception.

Exclusion Criteria

• Person under legal protection (legal protection, guardianship or curatorship),
• Person deprived of liberty by judicial or administrative decision,
• Person who is unable to give his/her non-opposition,
• Pregnant or breastfeeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	recording of the probe position	Patient with an echocardiography examination

Primary Outcome Measures

Name	Time	Method
Probe position	Day 0	Difference between actual probe position and predicted position with guidance algorithm

Secondary Outcome Measures

Name	Time	Method
Percentage of matches between algorithm and expert	Day 0

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France