Comparison of Non-invasive and Invasive Blood Pressure Monitors

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2024-04-18

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Blood Pressure Surgery Intensive Care Unit

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Single group design, patients are their own control.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

None, patients are their own control.

Study Groups

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Wrist one

Wrist one will have both the ViTrack wrist cuff on one wrist

Group Type EXPERIMENTAL

ViTrack

Intervention Type DEVICE

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

Wrist Two

Wrist two and the radial artery catheter in the opposite wrist.

Group Type ACTIVE_COMPARATOR

Radial artery catheterization

Intervention Type PROCEDURE

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

Interventions

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ViTrack

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

Intervention Type DEVICE

Radial artery catheterization

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No