Blood PressureNCT04506775

Comparison of Non-invasive and Invasive Blood Pressure Monitors

A study testing ViTrack and Radial artery catheterization in people with Blood Pressure and Surgery, run by University of Massachusetts, Worcester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Blood Pressure, Surgery, Intensive Care Unit
What is being tested?: ViTrack and Radial artery catheterization
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2020to 18 Apr 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Massachusetts Medical School
Worcester, Massachusetts, 01655

Other trials in United States

About this study

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

Read the 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.

Conditions: Blood Pressure, Surgery, Intensive Care Unit
Being tested: ViTrack, Radial artery catheterization
Keywords: Blood Pressure, BP, Surgery, Radial Artery Catheter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ViTrackDevice
ViTrack is a continuous non-invasive wearable blood pressure cuff.
Radial artery catheterizationProcedure or surgery
Radial artery catheterization is the standard of care for measuring blood pressure continuously throughout surgery.

Study groups in NCT04506775
Study group	Role	What they receive
Wrist one	Experimental	Wrist one will have both the ViTrack wrist cuff on one wrist Receives: Device: ViTrack
Wrist Two	Active comparator	Wrist two and the radial artery catheter in the opposite wrist. Receives: Procedure: Radial artery catheterization

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison of Diastolic Blood Pressure
255 time points compared across continuous blood pressure (mmHg)
As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be <5mmHg or <6mmHg and the standard deviation should be <8mmHg or <10mmHg respectively.
Measured: Up to 24 Hours
Comparison of Systolic Blood Pressure
255 time points compared across continuous blood pressure (mmHg)
As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be <5mmHg or <6mmHg and the standard deviation should be <8mmHg or <10mmHg respectively.
Measured: Up to 24 Hours

Secondary outcomes (1)

Skin Irritation
Examining for local skin irritation
Measured: Up to 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202018 Apr 2024

First posted10 Aug 2020
Study start1 Jan 2020
Primary completion18 Apr 2024
Study completion18 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Blood PressureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Model description: Single group design, patients are their own control.
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04506775
Sponsor's protocol ID: H00019883
Status last verified: Aug 2025
First submitted: 13 Jul 2020
Last updated: 10 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Results and de-identified data will be securely shared with the sponsor. Sponsor may only see subject initials and study ID #. All other data will de-identified for review purposes and transferred via a secure method following the universities data sharing agreement with the sponsor.

Publications

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.
PubMed 11137411

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of a Standalone, Continuous, Non-invasive Blood Pressure Monitor (cNIBP) to Radial Arterial Catheterization in Patients Undergoing Surgery.
ClinicalTrials.gov ID: NCT04506775
Acronym / sponsor ID: H00019883
Conditions: Blood Pressure, Surgery, Intensive Care Unit
Keywords: Blood Pressure, BP, Surgery, Radial Artery Catheter
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University of Massachusetts, WorcesterUniversity, hospital or other
Collaborators: Dynocardia, Inc
Study start: 1 Jan 2020 (actual)
Primary completion: 18 Apr 2024 (actual)
Study completion: 18 Apr 2024 (actual)
First posted: 10 Aug 2020 (actual)
Results: Posted 10 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: Single group design, patients are their own control.

Arm	Type	Receives
Wrist one	Experimental	Device: ViTrackWrist one will have both the ViTrack wrist cuff on one wrist
Wrist Two	Active comparator	Procedure: Radial artery catheterizationWrist two and the radial artery catheter in the opposite wrist.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ViTrackViTrack is a continuous non-invasive wearable blood pressure cuff.	Device	Wrist one
Radial artery catheterizationRadial artery catheterization is the standard of care for measuring blood pressure continuously throughout surgery.	Procedure or surgery	Wrist Two

Primary outcome

Comparison of Diastolic Blood Pressure
Time frame: Up to 24 Hours
255 time points compared across continuous blood pressure (mmHg) As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be <5mmHg or <6mmHg and the standard deviation should be <8mmHg or <10mmHg respectively.
Comparison of Systolic Blood Pressure
Time frame: Up to 24 Hours
255 time points compared across continuous blood pressure (mmHg) As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be <5mmHg or <6mmHg and the standard deviation should be <8mmHg or <10mmHg respectively.

1 secondary outcome

Skin Irritation
Time frame: Up to 72 hours

Results and safety

Results posted to the registry on 10 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	30	30

Primary outcome: Comparison of Diastolic Blood Pressure

Time frame: Up to 24 Hours. Mean (Standard Deviation). Unit: mmHg

Measure	All Study Participants n = 30
Value	0.90 (5.97)

All Study Participants: Mean Error: 0.90

Population analysed: Wrist 1, the ViTrack wrist cuff represents the experimental arm of the study. Wrist 2, the radial arterial catheter, represents the gold standard arterial blood pressure monitor that the ViTrack device is being compared to. The outcome DBP for the ViTrack device reports the mean error and standard deviation for the ViTrack device in comparison to the gold standard in alignment with the FDA standards.

Primary outcome: Comparison of Systolic Blood Pressure

Time frame: Up to 24 Hours. Mean (Standard Deviation). Unit: mmHg

Measure	All Study Participants n = 30
Value	0.19 (5.70)

All Study Participants: Mean Error: 0.19

Population analysed: Wrist 1, the ViTrack wrist cuff represents the experimental arm of the study. Wrist 2, the radial arterial catheter, represents the gold standard arterial blood pressure monitor that the ViTrack device is being compared to. The outcome SBP for the ViTrack device reports the mean error and standard deviation for the ViTrack device in comparison to the gold standard in alignment with the FDA standards.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Date of enrollment only. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Study Participants	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 11137411Heard 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.
Individual participant dataSharing planned: Yes. Results and de-identified data will be securely shared with the sponsor. Sponsor may only see subject initials and study ID #. All other data will de-identified for review purposes and transferred via a secure method following the universities data sharing agreement with the sponsor.

Related trials for Blood Pressure

RecruitingPhase 1
Understanding the Health Effect of a Bioactive Peptide From Egg: A Pilot Study
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Recruiting
The Sleep2BWell Trial
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Enrolling by invitation
MTM2MTG Pilot Ancillary Study
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James A Scott, DO principal investigator

University of Massachusetts, Worcester

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ViTrack and Radial artery catheterization in people with Blood Pressure and Surgery, run by University of Massachusetts, Worcester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of Diastolic Blood Pressure (time frame: Up to 24 Hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04506775, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.