Evaluation of TTE Utilization in Medical Surgery Step-Down Unit

Evaluation of TTE Utilization in Medical Surgery Step-Down Unit: Use of AI Assisted Point-of-Care Echo With Guidance Technology

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04203251

Enrollment

100

Registered

2019-12-18

Start date

2020-03-31

Completion date

2020-05-31

Last updated

2019-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease

Keywords

Artificial Intelligence, Cardiac Monitoring

Brief summary

This is a non-randomized, un-blinded study to evaluate Caption Health guidance software in patients in the medical surgery step-down unit. Patients will be scanned by a trained hospitalist and up to 4 standard views will be obtained per participant: PLAX, PSAX-PM, AP4 and SubC4. Observations will be made regarding human factors and performance of the device.

Interventions

DEVICECaption Health Guidance Technology

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Inclusion criteria

. * Patients ≥18 years old * Patients in the medical surgery step-down clinical setting * Patients who consent to participating in the study

Exclusion criteria

. * ● Patients with emergent or urgent episodes of injury and illness that can lead to death or disability without rapid intervention * Unable to lie flat for study * Patients experiencing a known or suspected acute cardiac event at the time of evaluation * Patients with severe chest wall abnormalities * Patients who have undergone pneumonectomy * Patients with recent abdominal surgery * Patients unwilling or unable to give written informed consent * Principal Investigator determination to exclude the subject from participation * Investigators also have the right to withdraw patient from the study in the event of illness, adverse events, or other reasons concerning the health or well-being of the patient, or in the case of non-compliance.

Design outcomes

Primary

Measure	Time frame	Description
Mean time to acquire images	Up to 3 months	Assess the time to acquire cardiac ultrasound images with and without Caption AI Gudiance
Percentage of attempted studies with clinically useful images	Up to 3 Months	Compare the percentage of clinically useful versus not useful images

Countries

United States

Contacts

Primary ContactJade Andora, BS

jade@captionhealth.com831-521-3821

Backup ContactSara Cosenza, MA

saracosenza@captionhealth.com301-512-8640

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026