Clinical trial NCT04506775: Comparison of Non-invasive and Invasive Blood Pressure Monitors
Official title: Comparison of a Standalone, Continuous, Non-invasive Blood Pressure Monitor (cNIBP) to Radial Arterial Catheterization in Patients Undergoing Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Surgery
Intensive Care Unit
Keywords: Blood Pressure
BP
Surgery
Radial Artery Catheter
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Dynocardia, Inc
First posted: 2020-08-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Single group design, patients are their own control.
Primary purpose: PREVENTION

Brief 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

Detailed description: 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.

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

Primary outcomes:
measure: Comparison of Diastolic Blood Pressure
timeFrame: Up to 24 Hours
measure: Comparison of Systolic Blood Pressure
timeFrame: Up to 24 Hours
Secondary outcomes:
measure: Skin Irritation
timeFrame: Up to 72 hours
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: James A Scott, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heard SO, Lisbon A, Toth I, Ramasubramanian R. An evaluation of a new continuous blood pressure monitoring system in critically ill patients. J Clin Anesth. 2000 Nov;12(7):509-18. doi: 10.1016/s0952-8180(00)00201-4.