NIBP Accuracy Validation in Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study collects non-invasive blood pressure data alongside invasive aortic pressure measurements to validate NIBP measurement algorithms. It follows IEC 80601-2-30:2018 and ISO 81060-2:2018+AMD2:2024 standards for clinical validation. Eligible participants are adults with suitable cuff sizes and an arterial line in place, excluding those with certain conditions or previous participation. Data will be gathered in a hospital setting to assess accuracy and performance of the NIBP standard parameter module. Lead sponsor is GE Healthcare, with the study conducted at Tower Hospital and the Heart and Lung Center in Helsinki.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age requirement: 18 and over.
2. 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).
3. Have an arterial line as a standard of care, which measures blood pressure at the aortic root.
4. Able to provide written informed consent.
5. Expected to remain in the unit for the duration of the study procedure.

Exclusion Criteria:

1. Have previously participated in this study (no subject may participate more than once).
2. Pregnant and lactating women per site standard of care.
3. Subjects with peripheral arterial diseases (causing left/right arm difference)
4. Hemodynamically unstable subjects at the discretion of the investigator.
5. Exhibited injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the Investigator, may prevent proper cuff application or functioning.
6. Are suffering from infection(s) or immunocompromised patients that require isolation.
7. PI or designee decision due to subject health conditions

Where it's running

• Tower Hospital, the Heart and Lung Center
  Helsinki, Finland Recruiting

Study contacts

• Study coordinator: Pasi Karjalainen
• Email: pasi.karjalainen@hus.fi
• Phone: + 358 40 5480853

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.