New blood pressure cuff tested against arterial lines in ICU patients
NCT ID NCT05673408
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 189 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Mayo Clinic Jacksonville
COMPLETEDJacksonville, Florida, 32224, United States
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Oregon Health & Science University
RECRUITINGPortland, Oregon, 97239, United States
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University Health Women's and Children's Hospital
RECRUITINGSan Antonio, Texas, 78229, United States
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University of Utah
TERMINATEDSalt Lake City, Utah, 84112, United States
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Wake Forest University Health Sciences
RECRUITINGWinston-Salem, North Carolina, 27157, United States
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