Advanced Wireless, Wearable Sensors for Continuous Hemodynamic Monitoring

• Sponsor: Northwestern University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04362553
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 26
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure	Device: wearable vital signs sensor

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Advanced Wireless, Wearable Sensors for Continuous Hemodynamic Monitoring
• Actual Study Start Date: Jun 1, 2020
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Adults Adults scheduled to receive a TTE (Trans-esophogeal echocardiogram)	Device: wearable vital signs sensor; vital signs monitoring during standard of care procedures; TTE, swan-ganz catheterization

Outcome Measures

Primary Outcome Measures

1. Percent agreement with pilot sensor and current standard of vital signs monitoring [2 years]

   Percent agreement with pilot sensor and current standard of vital signs monitoring

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All

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.).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shuai (Steve) Xu, Principal Investigator, Northwestern University
• ClinicalTrials.gov Identifier: NCT04362553
• Other Study ID Numbers: STU00210413
• First Posted: Apr 27, 2020
• Last Update Posted: Jun 9, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Jun 9, 2022