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New blood pressure cuff tested against arterial lines in ICU patients

NCT ID NCT05673408

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 checks if a new Philips blood pressure cuff and monitor gives accurate readings compared to the standard arterial line method. About 189 critically ill patients in ICUs or operating rooms will take part. The goal is to see if the non-invasive device can reliably measure blood pressure without needing an artery needle.

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 189 people

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

Started

Jun 2023

Expected to finish

Mar 2027

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

The clinical study will be conducted in neonate, infant, pediatric, and adult patients admitted into the NICU/PICU/ICU/OR.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Patient admitted into the NICU, PICU, ICU, or OR (operating room) * Adult aged 18 years and older, or parent/legal guardian of minor, willing and able to understand and provide informed consent/assent * Indication for NIBP cuff * Indication for radial arterial line for Subject Group 2 and Subject Group 3, and radial or umbilical arterial line for Subject Group 1 * Meet the following stratification criteria across the study: Stratification (per the ISO 81060-2:2018/Amd-2:2024): * Subject Group 1: * At least 3 patients shall be \<1000 g in weight * At least 3 patients shall be 1000 to 2000 g in weight * At least 3 patients shall be \> 2000 g in weight * At least 3 patients shall be ≥ 29 days and \< 1 year of age * At least 3 patients shall be ≥ 1 year and \< 3 years of age * The remaining patients may be from any of the above age or weight groups in order to complete the sample size * A patient can be in more than one category simultaneously * Subject Group 2: * At least 30% male, 30% female * Limb circumference distributed as specified in ISO81060-2:2018/Amd2:2024. * Subject Group 3: * At least 30% male, 30% female * Limb circumference distributed as specified in ISO81060- 2:2018/Amd-2:2024. * At least 10% SBP ≤ 100mmHg * At least 10% SBP ≥ 160mmHg * At least 10% DBP ≤ 70mmHg * At least 10% DBP ≥ 85mmHg Exclusion Criteria: * Inability to place the study device appropriately due to patient's anatomy or condition * Known pregnancy or lactating women (self-report) * Patients treated with an intra-aortic balloon pump * Aortic and mitral regurgitation (\> 2 nd degree) * Measurements taken in the lateral position * Currently participating in another clinical trial with any product, treatment and/or medication that clinically interferes with the study endpoint(s) * If valid SBP reference measurements for lateral difference is \> 15 mmHg (except for neonates with umbilical A-line) * If valid DBP reference measurements for lateral difference is \> 10 mmHg (except for neonates with umbilical A-line) * At the Principal Investigator's discretion, subject does not qualify to participate in the study for any reasons that are not mentioned above

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Conditions

The condition(s) this trial relates to.

Critical Illness

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

    3 sites. 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

  • Mayo Clinic Jacksonville

    COMPLETED

    Jacksonville, Florida, 32224, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • University Health Women's and Children's Hospital

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of Utah

    TERMINATED

    Salt Lake City, Utah, 84112, United States

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

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