Automated Non-Invasive Blood Pressure Study

The purpose of the study is to design and implement methods to make an algorithm to estimate blood pressure changes.

Study Overview

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

Detailed Description

Patient monitoring of blood pressure is essential for patient safety in hospitals. Automated non-invasive blood pressure (NIBP) uses data recorded with an SpO2 pulse oximeter to calculate a continuous estimate of blood pressure changes.

The purpose of the study is to design and implement methods to make an algorithm to estimate blood pressure changes.

This study will collect data for development of automated rules and evaluation of their performances in various clinical settings and to develop a larger clinical trial.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Erika Wilkman Principal Invastigator; Phone Number: +35894711; Email: erika.wilkman@hus.fi

Study Locations

• Finland
  • Helsinki, Finland, 00290
    • Recruiting
    • Helsinki University Hospital
    • Contact: Erika Wilkman Principal Investigator; Phone Number: + 35894711; Email: erika.wilkman@hus.fi
  • Helsinki, Finland, 00290
    • Not yet recruiting
    • Helsinki University Hospital
    • Contact: Erika Wilkman Principal Investigator; Phone Number: +35894711; Email: erika.wilkman@hus.fi

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients treated in Meilahti hospital

Description

Inclusion Criteria:

1. Able to provide written informed consent or have a LDR to provide written informed consent;
2. Are being cared for in OR, PACU or ICU and are expected to remain in the unit for the duration of the study procedure;
3. Have an invasive blood pressure measurement as a standard of care; AND
4. Are 18 years of age or older.

Exclusion Criteria:

1. Are known to be pregnant;
2. Are breastfeeding;
3. Are suffering from infection(s) that require isolation; OR
4. Have an external heart assistant device.
5. PI or caring physician decision due to subject health condition

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome Measure	The primary outcome is to collect SpO2 data using Automated Non-Invasive Blood Pressure from subjects in ICU, OR and PACU environment using the investigational system. This data will be used for engineering development purposes.	Up to 24 hours after time of enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Outcome	The safety outcome of this study are type and number of AEs, SAEs, and device deficiencies.	24 months

Collaborators and Investigators

• Sponsor: GE Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): April 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: August 24, 2026
• First Posted (Actual): August 27, 2026

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 24, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 225908091

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