Evaluation of TTE Utilization in Medical Surgery Step-Down Unit

NCT ID: NCT04203251

Last Updated: 2019-12-18

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

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-31

Study Completion Date

2020-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Disease

Keywords

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Artificial Intelligence Cardiac Monitoring

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Caption Health Guidance Technology

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Caption Health, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Central Contacts

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Jade Andora, BS

Role: CONTACT

Phone: 831-521-3821

Email: [email protected]

Sara Cosenza, MA

Role: CONTACT

Phone: 301-512-8640

Email: [email protected]

Facility Contacts

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Trevor Jensen, MD

Role: primary

Other Identifiers

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CHUCSF01

Identifier Type: -

Identifier Source: org_study_id