RecruitingNot Applicable

NIBP Accuracy Study for Adult Subject Populations

Finland130 participantsStarted 2025-01-13

Plain-language summary

The purpose of this study is to collect NIBP and invasive aortic pressure data from the clinical setting.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age requirement: 18 and over.
. Have an upper limb (right OR left side) that fits the cuff size of the device (circumference ranging 17 cm to 40 cm) OR have a thigh (right OR left side) that fits a cuff size of the device (circumference ranging 38 to 50 cm).
. Have an arterial line as a standard of care, which measures blood pressure at the aortic root.
. Able to provide written informed consent.
. Expected to remain in the unit for the duration of the study procedure.

Exclusion criteria

. Have previously participated in this study (no subject may participate more than once).
. Pregnant and lactating women per site standard of care.
. Subjects with peripheral arterial diseases (causing left/right arm difference)
. Hemodynamically unstable subjects at the discretion of the investigator.
. Exhibited injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the Investigator, may prevent proper cuff application or functioning.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary Outcome Measure

Timeframe: Up to 2 hours after time of enrollment

Trial details

NCT IDNCT07697950

SponsorGE Healthcare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Pasi Karjalainen

+ 358 40 5480853 pasi.karjalainen@hus.fi

View on ClinicalTrials.gov More Blood Pressure Measurement trials