NCT05490303

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 9, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

October 14, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

July 29, 2022

Last Update Submit

October 13, 2022

Conditions

Keywords

EchocardiographyGuidance algorithm

Outcome Measures

Primary Outcomes (1)

  • Probe position

    Difference between actual probe position and predicted position with guidance algorithm

    Day 0

Secondary Outcomes (1)

  • Percentage of matches between algorithm and expert

    Day 0

Study Arms (1)

Patients

OTHER

Patient with an echocardiography examination

Other: recording of the probe position

Interventions

For each patient, a cardiac ultrasound acquisition will be performed with an optical tracking system (infrared) recording the probe's position in real time.

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients (male or female) older than 18 years,
  • Patient having a scheduled cardiac ultrasound outside any emergency context,
  • Subjects affiliated or benefiting from a social security plan,
  • Women of childbearing age who are using effective contraception.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Stéphane LAFITTE, MD,PhD

    University Hospital, Bordeaux

    STUDY DIRECTOR

Central Study Contacts

Stéphane LAFITTE, MD,PhD

CONTACT

Bertrand MOAL, MD,PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2022

First Posted

August 5, 2022

Study Start

September 9, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

October 14, 2022

Record last verified: 2022-10

Locations