NIBP Accuracy Study for Adult

NCT07684859 | Withdrawn

• 1 other identifier: 226421268
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is developing new NIBP enhancement.

Conditions

Blood Pressure; Blood Pressure Measurement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Collection of safety information

  From admission to discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient treated in Meilahti Hospital Cath Lab

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Helsinki University Hospital

Helsinki, 00290, Finland

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: July 6, 2026
• Study Start: January 14, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 6, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)