Evaluation of TTE Utilization in Medical Surgery Step-Down Unit
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2019
CompletedFirst Posted
Study publicly available on registry
December 18, 2019
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedDecember 18, 2019
December 1, 2019
2 months
December 5, 2019
December 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Interventions
Eligibility Criteria
Patients in the medical surgery step down unit at UCSF.
You may qualify if:
- Patients ≥18 years old
- Patients in the medical surgery step-down clinical setting
- Patients who consent to participating in the study
You may not qualify if:
- ● 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2019
First Posted
December 18, 2019
Study Start
March 1, 2020
Primary Completion
May 1, 2020
Study Completion
May 1, 2020
Last Updated
December 18, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share