Home Monitoring clinical trials

Safety and Performance of NivolisMonitor and NivolisAnton for Monitoring Patients on Ventilatory Assistance at Home

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