NCT07790458

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
4mo left

Started Apr 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Apr 2025Dec 2026

First Submitted

Initial submission to the registry

March 31, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

April 14, 2025

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

1.7 years

First QC Date

March 31, 2025

Last Update Submit

August 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Safety Outcome

    24 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated in Meilahti hospital

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Helsinki University Hospital

Helsinki, 00290, Finland

NOT YET RECRUITING

Helsinki University Hospital

Helsinki, 00290, Finland

RECRUITING

Central Study Contacts

Erika Wilkman Principal Invastigator

CONTACT

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

August 27, 2026

Study Start

April 14, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations