Comparison of Non-invasive and Invasive Blood Pressure Monitors

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04506775
• Other study ID #: H00019883
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: July 6, 2024

Study information

• Verified date: February 2024
• Source: University of Massachusetts, Worcester
• Contact: Arlene Williams
• Phone: 5082316117
• Email: arlene.williams[@]umassmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 6, 2024
• Est. primary completion date: July 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Intensive Care Unit
• Surgery

Intervention

Device:
• ViTrack
ViTrack is a continuous non-invasive wearable blood pressure cuff.

Procedure:
• Radial artery catheterization
Radial artery catheterization is the standard of care for measuring blood pressure continuously throughout surgery.

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Diastolic Blood Pressure	255 time points compared across continuous blood pressure (mmHg)	Up to 24 Hours
Primary	Comparison of Systolic Blood Pressure	255 time points compared across continuous blood pressure (mmHg)	Up to 24 Hours
Secondary	Skin Irritation	Examining for local skin irritation	Up to 72 hours