Status:
COMPLETED
Comparison of Non-invasive and Invasive Blood Pressure Monitors
Lead Sponsor:
University of Massachusetts, Worcester
Collaborating Sponsors:
Dynocardia, Inc
Conditions:
Blood Pressure
Surgery
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
To compare a noninvasive and continuous radial artery blood pressure measurements utilizing ViTrack (developed by Dynocardia) to the standard of care radial artery catheterization, in patients undergo...
Detailed Description
The ViTrack is strapped over the radial artery at the wrist.The ViTrack blood pressure cuff will be utilized to obtain continuous blood pressure (BP) readings throughout the surgical procedure or inte...
Eligibility Criteria
Inclusion
- Patients between the ages of 18 - 90 years age who are undergoing any surgery or in the intensive care unit and require intra-arterial catheterization for continuous BP measurement.
- Patients having elective surgeries.
- Patients having emergent surgeries, but only if research staff can have appropriate time to review study with patient and obtain signature on fact sheet prior to administration of medications that could affect coherency.
- Patients who are able to review, verbalize understanding, and sign fact sheet. If patient has a health care proxy (HCP) or legal guardian, study will be reviewed, and signature of HCP or legal guardian will be obtained.
Exclusion
- Inability to obtain consent from the patient, HCP or legal guardian
- Greater than 10% difference in BP measurements between both arms prior to surgery
- Pregnant women
- Prisoners
- Inability to insert a radial artery catheter
- Any other condition that would increase the risk of participation in the study in the opinion of the site Investigator
- Upper extremity arteriovenous haemodialysis shunt
- Upper extremity amputation
- Surgical position/draping precludes access to the wrist.
- Wrist distortion or pain from arthritis
- Prior trauma or surgery at the radial artery monitoring site
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04506775
Start Date
January 1 2020
End Date
April 18 2024
Last Update
September 10 2025
Active Locations (1)
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1
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655