CARESCAPE Monitoring Systems ME Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Monitoring.
- Who it may be relevant to
- Registry conditions: Surgery, Intensive Care. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device Monitoring
Participants will be monitored with secondary monitor collecting data from parameters under evaluation
Primary outcome measures
- Clinical evaluation of the performance and usability [Time frame: From admission to discharge, maximum of 24 hours]
Secondary outcome measures (1)
- Collection of data [Time frame: From admission to discharge, maximum of 24 hours]
Eligibility criteria
Inclusion criteria
- Able to provide written informed consent or have a Legally Designated Representative (LDR) to provide written informed consent;
- Are being cared for in a hospital unit and are expected to remain in the unit for the duration of the study procedure; AND
- Parameter(s) in scope of the study can be collected
Exclusion criteria
- Are known to be pregnant;
- Are breastfeeding;
- Are suffering from infection(s) or immunocompromised patients that require isolation.
- Have an implantable pacemaker if investigational parameters NMT and/or respiration rate are under evaluation
- PI or designee decision due to subject's health condition
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Finland · 1 center
- Helsinki University Hospital — Espoo
Identifiers
NCT: NCT07024459 · 11897644380