NIBP Accuracy Study for Adult Subject Populations

Non-Invasive Blood Pressure Accuracy Study for Adult Subject Populations

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

Study Overview

• Status: Recruiting
• Conditions: Blood Pressure Measurement; Blood Pressure
• Intervention / Treatment: Device: NIBP Measurement

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.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pasi Karjalainen; Phone Number: + 358 40 5480853; Email: pasi.karjalainen@hus.fi

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • Tower Hospital, the Heart and Lung Center
    • Contact: Pasi Karjalainen; Phone Number: + 358 40 5480853; Email: pasi.karjalainen@hus.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Small Adult vs Adult Cuff (Upper Arm, Overlap Range 23-25 cm); 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.	Device: NIBP Measurement; 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.
Experimental: Adult vs Large Adult Cuff (Upper Arm, Overlap Range 31-33 cm); 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.	Device: NIBP Measurement; 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.
Experimental: Thigh Cuff (Fallback/Non-Randomized); 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.	Device: NIBP Measurement; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome Measure	Collection of non-invasive blood pressure measurements data from subjects in clinical setting.	Up to 2 hours after time of enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Safety Events	Analysis of adverse events will be listed per subject, summarized with counts and percentages of events, and summarized with counts and percentages of subjects with events.	24 months

Collaborators and Investigators

• Sponsor: GE Healthcare

Publications and helpful links

General 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.
• Whelton 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SA-000068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No