Evaluation of the Safety and Clinical Performance of NivolisMonitor and NivolisAnton: Medical Devices for Monitoring Patients Treated With Home Ventilatory Assistance Devices
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- VIVARDIS
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Use of the device expressed in Hours
研究概览
简要总结
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 :
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a selection of patients already treated with NIV or HDN according to the inclusion/non-inclusion criteria and submission of the information note
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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.
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a 3-day monitoring period:
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use over 3 days of the NivolisMonitor device at home, with on the last day the completion of the patient acceptability/usability questionnaire
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overnight use of NivolisAnton
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a teleconsultation to close the study for each patient
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completion of the healthcare professional acceptability/usability questionnaire at the end of the study
详细描述
Rationale :
Since the early 2000s, there has been growing interest in remote monitoring and telemonitoring of patients with chronic respiratory pathologies, in particular patients treated with Non-Invasive Ventilation (NIV). Thus, many studies have focused on the benefits of remote monitoring or telemonitoring. Although the concept of remote home ventilation monitoring seems intuitively useful, analysis of the literature indicates a need for trials with solid evidence. In the same way, nocturnal recording of transcutaneous capnia has shown its reliability and its interest for the follow-up of patients under respiratory assistance at home.
NivolisMonitor and NivolisAnton are new devices developed by Vivardis.
Study Design :
10 patients must be included in this one arm interventional study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
NivolisMonitor and NivolisAnton Arm
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.
干预措施: NivolisMonitor (Device)
NivolisMonitor and NivolisAnton Arm
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.
干预措施: NivolisAnton (Device)
结局指标
主要结局
Use of the device expressed in Hours
时间窗: At the end of the 3-day monitoring period
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.
FiO2 expressed as percent
时间窗: At the end of the 3-day monitoring period
NivolisMonitor measures FiO2 values of air delivered for Resmed NIV or Philipps NIV or HDN use. FiO2 is expressed as a median value.
Temperature Expressed in degree Celsius
时间窗: At the end of the 3-day monitoring period
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
Ventilatory frequency expressed in breaths.min-1
时间窗: At the end of the 3-day monitoring period
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.
Leaks expressed in L.min-1
时间窗: At the end of the 3-day monitoring period
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.
Air Flow expressed in L.min-1
时间窗: At the end of the 3-day monitoring period
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.
Relative Humidity expressed as percent RH
时间窗: At the end of the 3-day monitoring period
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.
TcPCO2 values expressed in mm Hg
时间窗: At the end of the 3-day monitoring period
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
Device Use expressed in Hours
时间窗: At the end of the 3-day monitoring period
NivolisMonitor measures use of device values for Resmed NIV or Philipps NIV or HDN devices. Use of device is expressed as a median value.
次要结局
- tcPCO2 corrected values expressed in mm Hg(At the end of the 3-day monitoring period)
- 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)
- Heart Rate (HR) in Beats Per Minute(At the end of the 3-day monitoring period)
- Health Practitioner Usability of NivolisAnton(At the end of the 3-day monitoring period)
- SaO2 expressed in %(At the end of the 3-day monitoring period)