Surgery, Intensive Care
Conditions
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.
Interventions
DEVICEMonitoring
Participants will be monitored with secondary monitor collecting data from parameters under evaluation
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Collection of safety information | From admission to discharge, maximum of 24 hours | Collection of number and type of AEs, SAEs and device issues |
Countries
Finland
Outcome results
None listed