NIBP Accuracy Study for Adult

Non-Invasive Blood Pressure Accuracy Study for Adult Subject Populations

The purpose of this study is developing new NIBP enhancement.

Study Overview

• Status: Withdrawn
• Conditions: Blood Pressure Measurement; Blood Pressure

Detailed Description

The measurement of blood pressure is an important physiological parameter in cardiovascular health. The accurate and continuous monitoring of blood pressure assures optimal care in various clinical settings. Blood pressure can be measured both by invasive and non-invasive methods. Measurement of blood pressure via arterial cannulation is the direct invasive clinical reference method. However, because invasive blood pressure measurement requires trained clinicians and involves potential complications, non-invasive blood pressure measurement is preferred. Non-invasive method uses non-invasive sphygmomanometers.

Non-invasive blood pressure measurement is based on the estimation of blood pressure. Because the accuracy in blood pressure measurement is essential to monitor patients, the reliability of non-invasive sphygmomanometers is required by internationally recognized standards. Safety and performance of automated sphygmomanometers are complied with IEC 80601-2-30:2018 and ISO 81060-2:2018: AMD2 (approved).

• Study Type: Observational

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00290
    • Helsinki University Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Patient treated in Meilahti Hospital Cath Lab

Description

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).
• Subjects with complications, who is on vasoactive agents at discretion of the PI.
• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of Non-Invasive Blood Pressures and Invasive Blood Pressures	The primary outcome will be the collection of blood non-invasive blood pressure measurements and invasive blood pressure measurements from adult, using NIBP Standard Parameter enhancement per ISO 81060-2 requirements. Per subject, Non-Invasive Blood Pressure and Invasive Blood Pressure endpoints are collected for: Systolic BP (mmHg) Diastolic BP (mmHg) NIBP and IBP Mean Arterial Blood Pressure (MAP)	From admission to discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of safety information	The safety outcome of this study is to collect safety information, including type and number of AEs, SAEs, and any device issues	From admission to discharge

Collaborators and Investigators

• Sponsor: GE Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2025
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 226421268

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