Evaluation of TTE Utilization in Medical Surgery Step-Down Unit

Cardiac Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04203251
• Other study ID #: CHUCSF01
• Status: Not yet recruiting
• Start date: March 2020
• Est. completion date: May 2020

Study information

• Verified date: December 2019
• Source: Caption Health, Inc.
• Contact: Jade Andora, BS
• Phone: 831-521-3821
• Email: jade[@]captionhealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

Device:
• Caption Health Guidance Technology

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Caption Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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