Advanced Wireless, Wearable Sensors for Continuous Hemodynamic Monitoring

NCT ID: NCT04362553

Last Updated: 2022-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-09-05

Brief Summary

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

Detailed Description

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Conditions

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Congestive Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adults

Adults scheduled to receive a TTE (Trans-esophogeal echocardiogram)

wearable vital signs sensor

Intervention Type DEVICE

vital signs monitoring during standard of care procedures; TTE, swan-ganz catheterization

Interventions

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wearable vital signs sensor

vital signs monitoring during standard of care procedures; TTE, swan-ganz catheterization

Intervention Type DEVICE

Eligibility Criteria

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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.).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Shuai (Steve) Xu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00210413

Identifier Type: -

Identifier Source: org_study_id

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