University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
NCT Number: NCT04506775
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 undergoing surgery or those who are being cared for in the intensive care unit
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Notify Me18 year–90 year
All sexes
Interventional
Not applicable
Worcester, Massachusetts, 01655, United States
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 intensive care unit. This will allow us to compare BP readings between the non-invasive ViTrack device and the standard of care invasive intra-arterial catheters readings. Data collection from both the ViTrack and arterial catheter occur in the opposite wrists.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ViTrack is a continuous non-invasive wearable blood pressure cuff.
Radial artery catheterization is the standard of care for measuring blood pressure continuously throughout surgery.
Time frame: Up to 24 Hours
255 time points compared across continuous blood pressure (mmHg)
As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be <5mmHg or <6mmHg and the standard deviation should be <8mmHg or <10mmHg respectively.
Time frame: Up to 24 Hours
255 time points compared across continuous blood pressure (mmHg)
As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be <5mmHg or <6mmHg and the standard deviation should be <8mmHg or <10mmHg respectively.
Time frame: Up to 72 hours
Examining for local skin irritation
University of Massachusetts, Worcester
Other
Comparison of a Standalone, Continuous, Non-invasive Blood Pressure Monitor (cNIBP) to Radial Arterial Catheterization in Patients Undergoing Surgery.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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