Diagnosis
Conditions
Keywords
Point of care ultrasound, Echocardiography
Brief summary
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.
Interventions
OTHERPoint 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.
Sponsors
Aisap LTD
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| POCUS QUALITY | 1 month | Primary endpoint: Percent of POCUS exams that attain the pre-specified POCUS image quality threshold (quality standard) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subgroup analysis | 1 month | Analysis of primary endpoint (POCUS exam quality) by the prespecified subgroups of age (above or below 65), gender, BMI group (below or above 25) and US device manufacturer. |
Countries
Israel, United States
Outcome results
None listed