CARESCAPE Monitoring Systems ME Study

Not Applicable

• Conditions: Surgery, Intensive Care

• Registration Number: NCT07024459
• Lead Sponsor: GE Healthcare

Brief Summary

Improving the reliability and accuracy of the current parameter measurement technologies is always based on measurement data to develop a newer generation. Different parameters from different age groups will be studied under this study protocol.

Detailed Description

Improving the reliability and accuracy of the current parameter measurement technologies is always based on measurement data to develop a newer generation.

In this study it is essential to gain data from different age groups; children, adults, and elderly people since they are targeted population to use the devices in the future. In different age groups, there is e.g., a different physiological factures that may affect the product under development.

Different parameters will be studied under this study protocol. To get real picture of these parameters investigated, it is essential to also collect data from other parameters, e.g., electrocardiogram (ECG), oxygen saturation (SpO2) and carbon dioxide (CO2, including CO2 derived respiration rate (RR)).

The results of this study are intended to be used in product development purposes and as an additional data to support conformity to the general safety and performance requirements of the Medical Device Regulation within device's Clinical Evaluation process. The study described herein is being conducted to collect feedback from the parameters studied, and to collect the parameter raw data from the patients in the hospital units using the investigational devices.

Study Timeline

• Study Start: 2024-06-13
• Status Verified: 2025-03
• Study First Submitted: 2025-03-31
• Study First Submitted QC: 2025-06-09
• Last Update Submitted: 2025-06-09
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Able to provide written informed consent or have a Legally Designated Representative (LDR) to provide written informed consent;
2. Are being cared for in a hospital unit and are expected to remain in the unit for the duration of the study procedure; AND
3. Parameter(s) in scope of the study can be collected

Exclusion Criteria

1. Are known to be pregnant;
2. Are breastfeeding;
3. Are suffering from infection(s) or immunocompromised patients that require isolation.
4. Have an implantable pacemaker if investigational parameters NMT and/or respiration rate are under evaluation
5. PI or designee decision due to subject's health condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical evaluation of the performance and usability	From admission to discharge, maximum of 24 hours	Primary outcome of this study is to conduct clinical evaluation of the performance and usability of the new software and hardware features introduced to the system by collecting data and surveys.

Secondary Outcome Measures

Name	Time	Method
Collection of data	From admission to discharge, maximum of 24 hours	The secondary study outcome will be reached when the minimum number of subjects with good raw data quality have been collected and analyzed for product development.

Trial Locations

Locations (1)

Helsinki University Hospital; 🇫🇮 Espoo, Uusimaa, Finland