NIBP Study for Neonate and Pediatric Subject Populations

Non-Invasive Blood Pressure Accuracy Study for Neonate and Pediatric Subject Populations

The purpose of this study is developing new NIBP enhancement and test it in clinical environment with neonates and children population subjects.

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): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Otto Rahkonen Principal Invastigator; Phone Number: +35894711; Email: otto.rahkonen@hus.fi

Study Locations

• Finland
  • Helsinki, Finland, 00290
    • Recruiting
    • Helsinki University Hospital
    • Contact: Otto Rahkonen Principal Investigator; Phone Number: +358094711; Email: otto.rahkonen@hus.fi

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age requirement: 0 to < 18 years.
• For children under 15 years old: Has a guardian or other legal representative who is able to provide consent of a guardian OR
• For children between the age of 15-17 years; able to provide written consent form and the legal guardians can be reached to be informed of the study participation.
• Have an upper limb (right OR left side) that fits the cuff size of the device (circumference ranging 3 cm to 33 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 invasive blood pressure.
• 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).
• Subjects with peripheral arterial diseases (causing left/right arm difference).
• Hemodynamically unstable subjects Subjects with complications on vasoactive agents at 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 subjects that require isolation.
• For adolescents of child-bearing potential, who are currently pregnant, suspected to be pregnant, or are currently lactating.
• PI, designee or caring physician 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Child Cuff vs Small Adult Cuff (Upper arm overlap, 17-19 cm); Subjects with an upper-arm circumference within 17-19 cm, where both Child Cuff and small adult cuffs are suitable, are randomized in a 1:1 ratio to receive blood pressure measurements using either: Child Cuff or Small Adult cuff Subjects with upper-arm circumferences in non-overlapping small adult -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.
Active Comparator: Small Adult vs Adult Cuff (Upper arm overlap, 23-25cm); 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.

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 12 hours from time of study procedure start

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Outcome	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.	6 months

Collaborators and Investigators

• Sponsor: GE Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

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: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SA-000054

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