CARESCAPE Monitoring Systems ME Study

General Electric (GE)

Status: Invitation-only

Conditions: Surgery, Intensive Care

Treatments: Device: Monitoring

Study type: Interventional

Funder types: Industry

Identifiers

NCT07024459

11897644380

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

data collection

Experimental group

Treatment:

Device: Monitoring