Kosmos Trio and Ejection Fraction Pivotal Study

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

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-04

Study Completion Date

2024-05-16

Brief Summary

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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

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Detailed Description

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Conditions

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Cardiac Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Subjects

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

Portable Ultrasound System

Intervention Type DEVICE

EchoNous KOSMOS

Interventions

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Portable Ultrasound System

EchoNous KOSMOS

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes