Comparison of Non-invasive and Invasive Blood Pressure Monitors (NCT04506775) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Non-invasive and Invasive Blood Pressure Monitors
United States30 participantsStarted 2020-01-01
Plain-language 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
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.