Safety and Performance Study of the MultiSense® Ambulatory Telemonitoring System for Non-critical Patient Management
- Conditions
- Visceral and Digestive SurgeryPost-surgical MonitoringPost-surgical Rehabilitation
- Interventions
- Device: MultiSense® remote monitoring
- Registration Number
- NCT05357729
- Lead Sponsor
- IHU Strasbourg
- Brief Summary
In this clinical investigation, the investigators will assess the safety, performances and clinical added value of the MultiSense® ambulatory telemonitoring solution in real-life situations.
- Detailed Description
The MultiSense® solution is a medical device for telemonitoring for in and outpatient use.
It includes 5 physiological data sensors and communicates via Bluetooth with a smartphone. The data is centralized in the web and a web application allows healthcare professionals to scrutinize patient's data.
Among its potential benefits, the MultiSense® solution offers continuous, non-invasive and wireless physiological data recording over 5 days whenever patient monitoring is needed. There is a special focus on the post-operative monitoring, especially during the initial convalescence phase outside the hospital. An automatic notification system can be set up by a healthcare professional to notify abnormal data and potential need for phone call and/or physical home intervention.
The aim of this study is to evaluate the safety, the performance and added value of the MultiSense® solution in real-life situations. The study population includes 20 post-surgical patients having a genuine need for post-hospital monitoring and be likely to have variations in physiological variables monitored, without being in a critical condition. The patients included will be equipped with the MultiSense® solution prior to the hospital discharge. The device will be used for 6 days from the date of actual deployment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Adult (male or female over 18 years) in non-critical care settings
- Patient programmed for an elective surgery
- Need to monitor at home at least one physiological parameter: heart rate, respiratory rate, SpO2, temperature, physical activity
- Patient able to use a smartphone
- Patient with Wi-Fi and/or Cellular connectivity at home
- Patient with a personal phone which allows to receive text messages
- Patient able to receive and understand information related to the study and give written informed consent
- Patient affiliated to the French social security system
- Patient with known skin allergy (adhesive or silicon) or skin disease that would not allow the use of an adhesive
- Patient with an active implantable device (such as a pacemaker or automatic defibrillator)
- Patient with an elective imagery planned during the use of MultiSense
- Pregnant or lactating patient
- Patient in exclusion period (determined by a previous or a current study)
- Patient under guardianship or trusteeship
- Patient under the protection of justice or deprived of liberty
- Patient in situation of emergency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MultiSense® remote monitoring MultiSense® remote monitoring The patients included will be equipped with the MultiSense® solution prior to the hospital discharge. The device will be used for 6 days from the date of actual deployment.
- Primary Outcome Measures
Name Time Method Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of heart rate accuracy by comparison with a reference monitor. From patch placement to hospital discharge, assessed up to 3 hours Accuracy is defined as an average measurement variation less than 5 bpm of the mean value, with respect to the reference standard
Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of data transmission. From patch placement to removal, assessed up to 7 days Data transmission is defined as more than 90% of data with transmission time from patch to server less than 5 min.
Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of data artefacts. From patch placement to removal, assessed up to 7 days Percentage of artefacts due to technical issues (non-behavioral events) over the monitoring period below 10% for heart rate, 20% for the respiratory rate or 30% for SpO2.
Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of data availability. From patch placement to removal, assessed up to 7 days Percentage of missing data due to technical issues (non-behavioral events) over the monitoring period below 15%.
- Secondary Outcome Measures
Name Time Method Patient's satisfaction and reassurance when monitored by the device From patch placement to its removal (up to 7 days) Determination of patient satisfaction and reassurance by an end-study questionnaire (4-levels Likert scale)
Device defects From patch placement to its removal (up to 7 days) Accounting of device deficiencies reported by the investigator, the patient or identified by MultiSense data analysis
MultiSense® data quality after moderate level of activity From patch placement to its removal (up to 7 days) Distribution of activity level across monitoring period, number of showers taken over the monitoring period and evolution of the artefact's metric (as defined in the primary endpoint) over time (MultiSense® data)
Patient's tolerance to prolonged use of the MultiSense® solution (Safety in use, side effects) From patch placement to its removal (up to 7 days) Accounting and classification of unexpected local and distant event due to the use of the MultiSense® solution (vigilance data) and Patient's questionnaire
Clinical relevance of the notifications provided by MultiSense® solution From patch placement to its removal (up to 7 days) Relevance of the notifications generated by MultiSense® will be judged on the relevance of the notification's functionality by the healthcare professional in real-life situation by the mean of notification treatment through MultiSense® web application
Remote monitoring facilitation for the healthcare professional through the solution's ease of use and satisfaction gained From patch placement to its removal (up to 7 days) Determination of healthcare professionals' practical interest in the solution and satisfaction of use assessed via a questionnaire (4-levels Likert scale)
Respiratory rate accuracy in terms of EtCO2 From patch placement to hospital discharge, assessed up to 3 hours Respiratory rate accuracy by comparison of MultiSense® data with the reference monitor in terms of EtCO2
Correlation between body temperature and skin temperature From patch placement to hospital discharge, assessed up to 2 days Correlation between the body temperature measured with a standard device and the skin temperature measured with the MultiSense® solution
Patch autonomy From patch placement to its removal (up to 7 days) Percentage of patches with an autonomy \> 5 days including skin adhesion and battery life (MultiSense® data and patient's questionnaire)
Respiratory rate accuracy in terms of impedance From patch placement to hospital discharge, assessed up to 3 hours Respiratory rate accuracy by comparison of MultiSense® data with the reference monitor in terms of impedance
Estimation of posture and activity level reported by the MultiSense® solution From patch placement to its removal (up to 7 days) Determination of the posture and activity level consistency by accounting the percentage of lying position and low activity at night and the percentage of high activity during day (MultiSense® data)
End of study hardware recovery rate From patch removal to material return, assessed up to 1 month Percentage of MultiSense® patch and gateway returned to RDS at the end of the study
Trial Locations
- Locations (1)
Service de Chirurgie Digestive et Endocrinienne
🇫🇷Strasbourg, France