Comparison of Non-invasive and Invasive Blood Pressure Monitors

Not Applicable

Completed

• Conditions: Blood Pressure; Intensive Care Unit; Surgery
• Interventions: Device: ViTrack; Procedure: Radial artery catheterization

• Registration Number: NCT04506775
• Lead Sponsor: University of Massachusetts, Worcester

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-10
• Primary Completion: 2024-04-18
• Study Completion: 2024-04-18
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Wrist one	ViTrack	Wrist one will have both the ViTrack wrist cuff on one wrist
Wrist Two	Radial artery catheterization	Wrist two and the radial artery catheter in the opposite wrist.

Primary Outcome Measures

Name	Time	Method
Comparison of Systolic Blood Pressure	Up to 24 Hours	255 time points compared across continuous blood pressure (mmHg)
Comparison of Diastolic Blood Pressure	Up to 24 Hours	255 time points compared across continuous blood pressure (mmHg)

Secondary Outcome Measures

Name	Time	Method
Skin Irritation	Up to 72 hours	Examining for local skin irritation

Trial Locations

Locations (1)

University of Massachusetts Medical School; 🇺🇸 Worcester, Massachusetts, United States