NCT07024459

CARESCAPE Monitoring Systems ME Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Surgery, Intensive Care

Interventions

Type	Name	Description
DEVICE	Monitoring	Participants will be monitored with secondary monitor collecting data from parameters under evaluation

Timeline

• Start date: 2024-06-13
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2025-06-17
• Last updated: 2025-06-17

Locations

1 site across 1 country: Finland