- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04362553
Advanced Wireless, Wearable Sensors for Continuous Hemodynamic Monitoring
September 27, 2022 updated by: Shuai (Steve) Xu, Northwestern University
Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
42
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Cardiology patients
Description
Inclusion Criteria
- Patient's aged 18-65
- 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
- Patient's with fragile skin or skin conditions that would prevent them from having a sensor placed
- Patients undergoing exercise or drug induced cardiac stress test
- 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.).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Adults
Adults scheduled to receive a TTE (Trans-esophogeal echocardiogram)
|
vital signs monitoring during standard of care procedures; TTE, swan-ganz catheterization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent agreement with pilot sensor and current standard of vital signs monitoring
Time Frame: 2 years
|
Percent agreement with pilot sensor and current standard of vital signs monitoring
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2020
Primary Completion (Actual)
November 23, 2020
Study Completion (Actual)
September 5, 2022
Study Registration Dates
First Submitted
April 15, 2020
First Submitted That Met QC Criteria
April 22, 2020
First Posted (Actual)
April 27, 2020
Study Record Updates
Last Update Posted (Actual)
September 28, 2022
Last Update Submitted That Met QC Criteria
September 27, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00210413
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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