Kosmos Trio and Ejection Fraction Pivotal Study

EchoNous

Status: Completed

Conditions: Cardiac Disease

Treatments: Device: Portable Ultrasound System

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06027164

ECHO-004

Details and patient eligibility

About

This is a single-group, observational study which will involve obtaining two echo scans of recruited patients. All recruited patients will undergo echo scans by both novice users (nurses) and experts (echo sonographers). Image quality between novices and experts as well as the ability to calculate LVEF from novice and expert scans and the quality of the LVEF calculated via KOSMOS-EF compared to LVEF calculations by expert cardiologists will occur in post-hoc Echo image analysis

Enrollment: 153 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 18-89 years of age
• Have capacity to provide written consent either themselves or via healthcare proxy as determined by subjects' clinical care teams
• Have an anticipated timeline in the EDOU long enough to allow for completion of study procedures without causing delay to subjects' usual clinical care

Exclusion criteria

• Heart rate > 110 beats per minute at the time of recruitment
• Pregnant women
• Prior chest surgery
• Chest wall deformities or injuries (i.e. wounds, infections, etc)
• Limited mobility precluding them from turning in bed independently
• Speak a primary language other than English or Spanish
• Vulnerable populations including: patients being evaluated for psychiatric crises, incarcerated individuals
• Unwilling or unable to consent to study procedures

Trial design

153 participants in 1 patient group

Study Subjects

Description:

Ultrasound scans conducted by novice users and experts on this cohort.

Treatment:

Device: Portable Ultrasound System