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Safety and Performance of NivolisMonitor and NivolisAnton for Monitoring Patients on Ventilatory Assistance at Home
Sponsor: VIVARDIS
Summary
NivolisMonitor and NivolisAnton are new devices developed by Vivardis. NivolisMonitor is a generic and autonomous device for remote monitoring of ventilatory parameters generated by ventilatory assistance systems. NivolisMonitor uses its sensors to measure ventilation parameters such as pressure, flow, temperature and relative humidity, Fi02 provided by respiratory treatment devices (NIV, HDN (High Nasal Flow) and Oxygen therapy). NivolisMonitor records this data, stores it and transmits it to the healthcare professionals in charge of the patient. NivolisAnton is a medical device for telemonitoring of transcutaneous capnia, it thus helps to make recordings at the patient's home and to transmit data to healthcare professionals. The main objective of this study is to show that the use of NivolisMonitor and NivolisAnton is done in complete safety and that the clinical performances of these two devices are achieved. For this, the data measured by NivolisMonitor will be compared with the data provided by the treatment devices used by patients at home and the data provided by NivolisAnton will be compared with the data reported by the transcutaneous capnia monitor. The secondary objectives concern the evaluation of the acceptability/usability of the devices by patients and healthcare professionals. This evaluation will take the form of an observational clinical study on 10 patients, including : * a selection of patients already treated with NIV or HDN according to the inclusion/non-inclusion criteria and submission of the information note * an inclusion visit taking place during a routine pulmonological follow-up visit for these patients with collection of the free and informed consent of each patient. The blood gas data collected during this routine consultation will be compiled in the study observation book. * a 3-day monitoring period: * use over 3 days of the NivolisMonitor device at home, with on the last day the completion of the patient acceptability/usability questionnaire * overnight use of NivolisAnton * a teleconsultation to close the study for each patient * completion of the healthcare professional acceptability/usability questionnaire at the end of the study
Official title: Evaluation of the Safety and Clinical Performance of NivolisMonitor and NivolisAnton: Medical Devices for Monitoring Patients Treated With Home Ventilatory Assistance Devices
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2023-04-24
Completion Date
2025-12-31
Last Updated
2024-04-29
Healthy Volunteers
No
Interventions
NivolisMonitor
NivolisMonitor comprises a sensing element and controller to measure respiratory values, such as pressure and flow optionnally temperature, relative humidity and oxygen concentration, of a patient being treated with a respiratory therapy devices NIV, CPAP or HDN. NivolisMonitor is inserted between the respiratory assistance device and the mask or cannula inline with the standard patient circuit used routinely with the respiratory assistance device. NivolisMonitor functions are: * measure the respiratory values from the builtin sensor (Pressure, Flow, Temperature, Humidity, Oxygen fraction), * store the measurements in the embedded memory * extract from the measurement basic respiratory markers: * detect if and when a patient is using the respiratory assist device, * calculate leakage * calculate respiratory frequency * transmit the measured values via the NivolisBox component to NivolisPortal
NivolisAnton
NivolisAnton device enables wireless and remote communication from tcPCO2 monitors which measure transcuteanously CO2 and O2 partial pressures in the blood (tcPCO2 \& tcPO2) . NivolisAnton device connects to the serial port of tcPCO2 monitor, detects if the monitor is actively measuring blood gas values, collects the measurements from the monitor by following manufacturer's communication protocol and stores the collected values in its internal memory. When applicable per the manufacturer recommendations, NivolisAnton collects the values to apply the drift correction as per the manufacturer recommendations. NivolisAnton transmits the collected data to external receiving devices, such as Medical Devices (NivolisMonitor or another Medical Device that is granted approved data access by Vivardis) via Bluetooth or data servers (NivolisBox as an example) via WIFI. This data is thereafter transmitted by previously mentioned devices to the NivolisPortal server for archiving.
Locations (1)
CHU Grenoble Alpes
Grenoble, France