N/A
N=30
Comparison of Non-invasive and Invasive Blood Pressure Monitors
Blood Pressure · Surgery · Intensive Care Unit
Bottom Line
View on ClinicalTrials.gov: NCT04506775 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Comparison of Diastolic Blood Pressure — 0.90 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ViTrack (Device); Radial artery catheterization (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Massachusetts, Worcester
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Diastolic Blood Pressure |
0.90 | — |
| PRIMARY Comparison of Systolic Blood Pressure |
0.19 | — |
| SECONDARY Skin Irritation |
— | — |
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 undergoing surgery or those who are being cared for in the intensive care unit
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04506775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.