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Could a simple cuff replace needles for blood pressure monitoring in the ICU?

NCT ID NCT06895590

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new upper-arm blood pressure cuff (Philips AMC) to see if it can measure blood pressure and fluid needs as accurately as the standard invasive arterial line. About 205 adults having surgery who already need both a cuff and an arterial line will take part. The goal is to see if the cuff can provide reliable readings without the risks of an arterial line.

What this could mean

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

Active substance
Philips Advanced Monitoring Cuff (AMC) - a non-invasive upper arm blood pressure cuff
What this could lead to
If successful, this cuff could provide a less invasive way to measure blood pressure and fluid needs in surgical ICU patients, potentially reducing the need for arterial lines.
What could go wrong
This is an early-stage device comparison study, not a treatment trial. The cuff may not match the accuracy of invasive monitoring, and results may not apply to all patient groups.

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.

Participants

About 205 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Feb 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Up to 205 non-cardiac surgical or Intensive Care Unit (ICU) patients being monitored with a radial arterial line will be enrolled over approximately 8 months accrual and follow-up evaluation period.

Ages

18 years and older

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: * Adults aged 18 years and older * Indication for NIBP cuff * Indication for a radial arterial line * Subject or legal authorized representative is able to understand and speak the local language (also Spanish for US sites) to provide voluntary written informed consent prior to study procedures The following stratification criteria must be met across the study sites and hence targeted enrollment may be required: * Age of every patient 18+; at least 30% \> 65 years, 30% ≤ 65 years * At least 30% male, 30% female * Minimum number of subjects needed to test each size cuff (per ISO81060-2:2018/AMD2:2024, based on limb circumference range): * Adult Small (19-27 cm) = 165\*\[8/(2\*24)\] = 28 * Adult (25-34 cm) = 165\*\[9/(2\*24)\] = 31 * Adult Large Short (30-40 cm with severely conical arm) = 165\*\[10/(2\*24)\] = 35 * Adult Large (32-43 cm) = 165\*\[11/(2\*24)\] = 38 * At least 40% of the subjects within each cuff size shall have a limb circumference that lies within the upper half of the specified range of use of the cuff * At least 40% of the subjects within each cuff size shall have a limb circumference within the lower half of the specified range of use of the cuff * At least 10% SBP measurements ≤ 100 mmHg * At least 10% SBP measurements ≥ 160 mmHg * At least 10% DBP measurements ≤ 70 mmHg * At least 10% DBP measurements ≥ 85 mmHg Exclusion Criteria: * Emergency surgery * Surgeries in which both arms are tucked * Inability to place the Philips AMC appropriately due to subject anatomy or condition * Known pregnancy or lactating women (self-report) * Patients treated with an intra-aortic balloon pump * Aortic and mitral regurgitation (\> 2nd degree), if known * Measurements taken in the lateral position * Pressure of the arterial line system, when tested at 100 mmHg with the VeriCal device, exceeds the +/- 2 mmHg threshold * Currently participating in an investigational drug or another device study that clinically interferes with the study endpoints * Upper arm circumference \< 19 cm or \> 43 cm * BMI \> 45 * If the average of 3 baseline NIBP lateral difference measurements for SBP is \> 15 mmHg or for DBP is \> 10 mmHg * At the PI's discretion, subject does not qualify to participate in the study for any reasons that are not mentioned above

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As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke University Health System

    RECRUITING

    Durham, North Carolina, 27710, United States

  • LMU Klinikum , Campus Großhadern

    RECRUITING

    München, Bavaria, 81377, Germany

  • Wake Forest Baptist Medical Center

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

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