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HeartGuide: Preliminary Study (HG-1)

U

University Hospital of Bordeaux

Status

Enrolling

Conditions

Cardiac Disease

Treatments

Other: recording of the probe position

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05490303
CHUBX 2022/19
2022-A01501-42 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

90 participants in 1 patient group

Patients
Other group
Description:
Patient with an echocardiography examination
Treatment:
Other: recording of the probe position

Trial contacts and locations

1

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Central trial contact

Stéphane LAFITTE, MD,PhD; Bertrand MOAL, MD,PhD

Data sourced from clinicaltrials.gov

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