Advanced Wireless, Wearable Sensors for Continuous Hemodynamic Monitoring

Congestive Heart Failure Clinical Trial

Official title:

Advanced Wireless, Wearable Sensors for Continuous Hemodynamic Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04362553
• Other study ID #: STU00210413
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: September 5, 2022

Study information

• Verified date: September 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 5, 2022
• Est. primary completion date: November 23, 2020
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria

1. Patient's aged 18-65

2. Patient's scheduled to undergo a Trans-thoracic Echocardiogram (TTE) in an outpatient cardiology clinic or admitted to the Cardiac Care Unit with a swan ganz catheter in place for continuous invasive hemodynamic monitoring

Exclusion Criteria

1. Patient's with fragile skin or skin conditions that would prevent them from having a sensor placed

2. Patients undergoing exercise or drug induced cardiac stress test

3. Patients with a visible wound at site of sensor placement 3.4. Patients with structural or functional limitations to peripheral blood flow (known upper extremity peripheral arterial disease, use of vasopressors etc.).

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• wearable vital signs sensor
vital signs monitoring during standard of care procedures; TTE, swan-ganz catheterization

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent agreement with pilot sensor and current standard of vital signs monitoring	Percent agreement with pilot sensor and current standard of vital signs monitoring	2 years