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Could a simple arm cuff replace the need for an artery needle during surgery?

NCT ID NCT04506775

Knowledge-focused Sponsor: University of Massachusetts, Worcester Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a wearable, non-invasive blood pressure monitor called ViTrack against the standard method of placing a small tube in the wrist artery. Researchers compared blood pressure readings from 30 surgery or ICU patients at 255 time points. The goal was to see if the cuff is accurate enough to replace the more invasive catheter.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If the ViTrack device proves accurate, it could offer a less invasive way to continuously monitor blood pressure during surgery or in the ICU.
What could go wrong
This is a small, early-stage comparison study with only 30 participants. The device may not meet accuracy standards or could cause skin irritation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

30 people

The number who actually took part.

Started

Jan 2020

Finished

Apr 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hypertensive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Blood pressure Intensive care unit Surgery

Contacts and locations

Locations

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.