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

NCT05698602 | Active Not Recruiting

• 1 other identifier: Nivolis
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Respiratory Insufficiency; Respiratory Failure; Home Monitoring

Keywords

Noninvasive ventilation; Nasal High Flow; Home Monitoring; Transcutaneous CO2 pressure

Outcome Measures

Primary Outcomes (9)

• Ventilatory frequency expressed in breaths.min-1

  The values of ventilatory frequency assessed by NivolisMonitor will be compared to ventilatory frequency values measured by Resmed NIV or Philipps NIV. Ventilatory frequency is expressed as a median or average value, and compared according to the used NIV, respectively : Median for Resmed NIV and Average for VNI Philipps.

  At the end of the 3-day monitoring period

• Leaks expressed in L.min-1

  The values of Leaks assessed by NivolisMonitor will be compared to leaks values measured by Resmed NIV or Philipps NIV. Leaks are expressed as a median or average value, and compared according to the used NIV, respectively : Median for Resmed NIV and Average for VNI Philipps.

  At the end of the 3-day monitoring period

• Use of the device expressed in Hours

  The values of Use of the NIV device assessed by NivolisMonitor will be compared to Use of the device values measured by Resmed NIV or Philipps NIV. Use of the device is expressed as a median or average value, and compared according to the used NIV, respectively : Median for Resmed NIV and Average for VNI Philipps.

  At the end of the 3-day monitoring period

• Air Flow expressed in L.min-1

  The values of Air Flow assessed by NivolisMonitor will be compared to Air Flow values prescribed for Resmed NIV or Philipps NIV or HDN devices. Air Flow is expressed as a median value.

  At the end of the 3-day monitoring period

• FiO2 expressed as percent

  NivolisMonitor measures FiO2 values of air delivered for Resmed NIV or Philipps NIV or HDN use. FiO2 is expressed as a median value.

  At the end of the 3-day monitoring period

• Temperature Expressed in degree Celsius

  NivolisMonitor measures Temperature values of air delivered for Resmed NIV or Philipps NIV or HDN use. Temperature is expressed as a median value. Median Temperature Expressed in degree Celsius

  At the end of the 3-day monitoring period

• Relative Humidity expressed as percent RH

  NivolisMonitor measures relative humidity values of air delivered for Resmed NIV or Philipps NIV or HDN use. Relative humidity is expressed as a median value.

  At the end of the 3-day monitoring period

• Device Use expressed in Hours

  NivolisMonitor measures use of device values for Resmed NIV or Philipps NIV or HDN devices. Use of device is expressed as a median value.

  At the end of the 3-day monitoring period

• TcPCO2 values expressed in mm Hg

  NivolisAnton collects tcPCO2 values from Sentec SDM monitor. tcPCO2 value, collected by NivolisAnton, expressed in average during the overnight recording will be compared to tcPCO2 value measured by Sentec SDM monitor

  At the end of the 3-day monitoring period

Secondary Outcomes (6)

• Patient Usability of NivolisMonitor

  At the end of the 3-day monitoring period

• Health Practitioner Usability of NivolisMonitor

  At the end of the 3-day monitoring period

• Health Practitioner Usability of NivolisAnton

  At the end of the 3-day monitoring period

• tcPCO2 corrected values expressed in mm Hg

  At the end of the 3-day monitoring period

• SaO2 expressed in %

  At the end of the 3-day monitoring period

Study Arms (1)

NivolisMonitor and NivolisAnton Arm

EXPERIMENTAL

For each patient enrolled in the study, a NivolisMonitor device is added to the usual ventilatory device for 3 days. NivolisMonitor is connected to the patient circuit, between the ventilatory device and the patient interface, ideally at the patient end of the circuit or possibly at the end of the breathing support device of the circuit (NIV or HDN). NivolisMonitor continuously measures pressure (P in cm H20) and flow (F in L.min-1) as well as temperature (T in degree Celsisus), relative humidity (RH in percent RH) and, optionally, the Fi02 (in percent). In addition, an overnight transcutaneous capnia recording will be performed using a Sentec SDM monitor to which a NivolisAnton device will be connected and will be able to collect data and transmit it via remote monitoring.

Device: NivolisMonitor; Device: NivolisAnton

Interventions

NivolisMonitor DEVICE

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

NivolisMonitor and NivolisAnton Arm

NivolisAnton DEVICE

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.

NivolisMonitor and NivolisAnton Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients treated with home ventilatory devices: NIV (Philipps Dreamstation or Resmed Lumis) or HDN
• COPD patient treated with NIV or HDN according to current recommendations
• Patient with Obesity Hypoventilation Syndrome treated with NIV or HDN according to current recommendations

You may not qualify if:

• Progressive and life-threatening condition in the short term (1 year) (cancer, rapidly progressing neuromuscular disease) (at physician's discretion)
• Patients treated with NIV other than Philipps Dreamstation or Resmed Lumis
• Hospitalization leading to NIV discontinuation for at least 1 week during the screening phase
• Person deprived of liberty
• Adult protected by law
• Pregnant and breastfeeding women

Sponsors & Collaborators

• VIVARDIS: lead

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38, France

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Jean-Louis Pépin, Professor

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 26, 2023
• Study Start: April 24, 2023
• Primary Completion: July 1, 2025
• Study Completion: December 31, 2025
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)