Prospective Acquisition of Cardiac Ultrasound Images at the Point of Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-23

Study Completion Date

2023-06-30

Brief Summary

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The present study is a preparatory step towards a multi-reader multi case (MRMC) randomized fully crossed study. As POCUS images are frequently not stored and not methodically acquired using a standardized image acquisition protocol this study will collect cardiac POCUS images in a prespecified manner.

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Detailed Description

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Conditions

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Diagnosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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POCUS acquisition

Prospective noninterventional single arm study collection of cardiac POCUS examination according to prespecified acquisition protocol.

Alongside POCUS images the study will also collect demographic and clinical information from the study participants and some information from the healthcare personal performing the POCUS exam (experience in US image acquisition, physician specialty or sonographer).

Patient management will not be impacted, and usual care will follow the regular practices at the study site.

Point of care ultrasound cardiac examination

Intervention Type OTHER

The study intervention consists of a POCUS cardiac examination by site approved personal using an FDA cleared US scanner. Usual care of study participants will not be impacted.

Interventions

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Point of care ultrasound cardiac examination

The study intervention consists of a POCUS cardiac examination by site approved personal using an FDA cleared US scanner. Usual care of study participants will not be impacted.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 21 or more

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Unstable clinical condition according to PI clinical judgment
2. Presence of prosthetic cardiac valve at any position and any type
3. Pregnancy or lactation
4. Contact isolation due to infections disease
5. Presence of left ventricular assist device (LVAD)
6. Know existence of congenital heart disease
7. Prosthetic cardiac valve, any
8. BMI 40 or greater
9. Clinical conditions that do not permit a POCUS study according to the judgment of the investigators or treating physicians
10. History of lung resection
11. Known poor cardiac US image quality based on prior echo exams
12. Mechanical ventilation, or other situations where the required ultrasound views cannot be adequately obtained
13. Clinical instability or critical subject condition or any condition the study PI judges that the POCUS exam could adversely affect the participant

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes