Blood PressureNCT07628296
Non-Invasive Blood Pressure Accuracy Study for Adult Subject Populations
A study testing NIBP Measurement in people with Blood Pressure and Blood Pressure Measurement, run by GE Healthcare at 1 site in Finland.
Trial summary
The purpose of this study is to collect NIBP and invasive aortic pressure data from the clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Blood Pressure Measurement
- What is being tested?
- NIBP Measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFinland
- Study dates
- 19 May 2026to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Are suffering from infection(s) or immunocompromised patients that require isolation.
- PI or designee decision due to subject health conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Tampere Heart Hospital
Tampere
Jussi Hernesniemi, +358 (0)50 436 1303, jussi.hernesniemi@sydansairaala.fi
About this study
The purpose of this study is to collect NIBP and invasive aortic pressure data from the clinical setting.
Read the detailed description
The purpose of the study is to collect clinical data for validation of the accuracy of non-invasive blood pressure (NIBP) measurement algorithms on the Non-invasive Blood Pressure (NIBP) Standard Parameter Module (SPM) per IEC 80601-2-30:2018, Medical electrical equipment-Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers standard, section 201.106. In addition, the study will be conducted per ISO 81060-2:2018+AMD2:2024 Non-invasive sphygmomanometers-Part 2: Clinical investigation of intermittent automated measurement type.
- Conditions
- Blood Pressure, Blood Pressure Measurement
- Being tested
- NIBP Measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIBP MeasurementDevice
The collection of non-invasive blood pressure measurements using NIBP Standard Parameter Module with SuperSTAT algorithm with simultaneous invasive blood pressure waveform recordings per discretion of the sponsor upon combining the data from other clinical studies to comply with ISO 81060-2:2018 +AMD2:2024.
| Study group | Role | What they receive |
|---|---|---|
| Small Adult vs Adult Cuff (Upper Arm, Overlap Range 23-25 cm) | Experimental | Subjects with an upper-arm circumference within 23-25 cm, where both Small Adult (SA) and Adult (A) cuffs are suitable, are randomized in a 1:1 ratio to receive blood pressure measurements using either:
* Small Adult cuff, or
* Adult cuff
Subjects with upper-arm circumferences in non-overlapping SA-only ranges are assigned the Small Adult cuff without randomization and are not included in this arm. Receives: Device: NIBP Measurement |
| Adult vs Large Adult Cuff (Upper Arm, Overlap Range 31-33 cm) | Experimental | Subjects with an upper-arm circumference within 31-33 cm, where both Adult (A) and Large Adult (LA) cuffs are suitable, are randomized in a 1:1 ratio to receive blood pressure measurements using either:
Adult cuff, or Large Adult cuff
Subjects with measurements in non-overlapping A-only or LA-only ranges are assigned the appropriate cuff without randomization and are not included in this arm. Receives: Device: NIBP Measurement |
| Thigh Cuff (Fallback/Non-Randomized) | Experimental | Subjects whose arm circumference is either:
* Outside the allowable upper-arm range (17-40 cm), or
* Eligible but excluded due to fulfillment of upper-arm cuff quotas
will undergo thigh circumference measurement. Those with a thigh circumference within 38-50 cm will receive blood pressure measurements using a thigh cuff.
Subjects outside the thigh circumference range are excluded prior to any blood pressure measurements. Receives: Device: NIBP Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
Collection of non-invasive blood pressure measurements data from subjects in clinical setting.
Measured: Up to 2 hours after time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start19 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628296
- Sponsor's protocol ID
- SA-000259
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meidert AS, Saugel B. Techniques for Non-Invasive Monitoring of Arterial Blood Pressure. Front Med (Lausanne). 2018 Jan 8;4:231. doi: 10.3389/fmed.2017.00231. eCollection 2017.
PubMed 29359130Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2018 Oct 23;138(17):e426-e483. doi: 10.1161/CIR.0000000000000597. No abstract available.
PubMed 30354655