An interventional study of Monitoring in Surgery, Intensive Care, sponsored by GE Healthcare. Enrolling by invitation at 1 site in Finland. Per ClinicalTrials.gov, last updated 2025-06-17.
Sponsored by GE Healthcare · Not applicable, Interventional, and Diagnostic
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.
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.
GE Healthcare is the lead sponsor of 168 studies on the registry; 19 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Monitoring
Participants will be monitored with secondary monitor collecting data from parameters under evaluation
Clinical evaluation of the performance and usability
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.
Time frame: From admission to discharge, maximum of 24 hours
Collection of data
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.
Time frame: From admission to discharge, maximum of 24 hours
Collection of safety information
Collection of number and type of AEs, SAEs and device issues
Time frame: From admission to discharge, maximum of 24 hours
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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GE Healthcare