Could a simple cuff replace needles for blood pressure monitoring in the ICU?
NCT ID NCT06895590
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
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About 205 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Feb 2026
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
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
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18 years and older
- 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: * 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.
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The places running it
4 sites in 2 countries. 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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Beth Israel Deaconess Medical Center
RECRUITINGBoston, Massachusetts, 02215, United States
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Duke University Health System
RECRUITINGDurham, North Carolina, 27710, United States
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LMU Klinikum , Campus Großhadern
RECRUITINGMünchen, Bavaria, 81377, Germany
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Wake Forest Baptist Medical Center
RECRUITINGWinston-Salem, North Carolina, 27157, United States
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