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

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.

Study Overview

• Status: Unknown
• Conditions: Cardiac Disease
• Intervention / Treatment: Device: Caption Health Guidance Technology

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in the medical surgery step down unit at UCSF.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Caption Health, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 16, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Cardiac Monitoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: CHUCSF01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No