Comparison of Non-invasive and Invasive Blood Pressure Monitors

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Comparison of a Standalone, Continuous, Non-invasive Blood Pressure Monitor (cNIBP) to Radial Arterial Catheterization in Patients Undergoing Surgery.

Conditions
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Blood Pressure, Surgery, Intensive Care Unit

Intervention / Treatment
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* Device: ViTrack
* Procedure: Radial artery catheterization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Single group design, patients are their own control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wrist one<br>Wrist one will have both the ViTrack wrist cuff on one wrist | Device: ViTrack<br>* ViTrack is a continuous non-invasive wearable blood pressure cuff.<br>|
| Active Comparator: Wrist Two<br>Wrist two and the radial artery catheter in the opposite wrist. | Procedure: Radial artery catheterization<br>* Radial artery catheterization is the standard of care for measuring blood pressure continuously throughout surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Diastolic Blood Pressure | 255 time points compared across continuous blood pressure (mmHg) | Up to 24 Hours | 
| Comparison of Systolic Blood Pressure | 255 time points compared across continuous blood pressure (mmHg) | Up to 24 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Irritation | Examining for local skin irritation | Up to 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Pressure, BP, Surgery, Radial Artery Catheter