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Evaluation of TTE Utilization in Medical Surgery Step-Down Unit

C

Caption Health

Status

Unknown

Conditions

Cardiac Disease

Treatments

Device: Caption Health Guidance Technology

Study type

Observational

Funder types

Industry

Identifiers

NCT04203251
CHUCSF01

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial contacts and locations

1

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Central trial contact

Jade Andora, BS; Sara Cosenza, MA

Data sourced from clinicaltrials.gov

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