Evaluation of TTE Utilization in Medical Surgery Step-Down Unit

• Conditions: Cardiac Disease

• Registration Number: NCT04203251
• Lead Sponsor: Caption Health, Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-16
• Last Update Submitted: 2019-12-16
• Study First Posted: 2019-12-18
• Last Update Posted: 2019-12-18
• Study Start: 2020-03
• Primary Completion: 2020-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States