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
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
30
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.
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Comparison of Diastolic Blood Pressure
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
Comparison of Systolic Blood Pressure
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
Skin Irritation
Examining for local skin irritation
Time frame: Up to 72 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.