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| Name | Class |
|---|---|
| Rhythm Diagnostic Systems | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MultiSense® remote monitoring | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MultiSense® remote monitoring | Device | At hospital, the patient will be monitored with conventional monitoring devices as well as the MultiSense® solution (at least one hour with a reference monitor). After hospital discharge, the patients will be remotely monitored by their healthcare professional using the MultiSense® solution. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Accuracy is defined as an average measurement variation less than 5 bpm of the mean value, with respect to the reference standard | From patch placement to hospital discharge, assessed up to 3 hours |
| Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of data availability. | Percentage of missing data due to technical issues (non-behavioral events) over the monitoring period below 15%. | From patch placement to removal, assessed up to 7 days |
| Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of data artefacts. | 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. | From patch placement to removal, assessed up to 7 days |
| Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of data transmission. | Data transmission is defined as more than 90% of data with transmission time from patch to server less than 5 min. | From patch placement to removal, assessed up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's tolerance to prolonged use of the MultiSense® solution (Safety in use, side effects) | Accounting and classification of unexpected local and distant event due to the use of the MultiSense® solution (vigilance data) and Patient's questionnaire | From patch placement to its removal (up to 7 days) |
| Device defects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel VIX, MD | Service de Chirurgie Digestive, NHC, HUS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Chirurgie Digestive et Endocrinienne | Strasbourg | 67000 | France |
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Accounting of device deficiencies reported by the investigator, the patient or identified by MultiSense data analysis |
| From patch placement to its removal (up to 7 days) |
| Clinical relevance of the notifications provided by MultiSense® solution | 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 a questionnaire (4-levels Likert scale) | From patch placement to its removal (up to 7 days) |
| Clinical relevance of the notifications provided by MultiSense® solution | 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 | From patch placement to its removal (up to 7 days) |
| Remote monitoring facilitation for the healthcare professional through the solution's ease of use and satisfaction gained | Determination of healthcare professionals' practical interest in the solution and satisfaction of use assessed via a questionnaire (4-levels Likert scale) | From patch placement to its removal (up to 7 days) |
| Patient's satisfaction and reassurance when monitored by the device | Determination of patient satisfaction and reassurance by an end-study questionnaire (4-levels Likert scale) | From patch placement to its removal (up to 7 days) |
| Patch autonomy | Percentage of patches with an autonomy > 5 days including skin adhesion and battery life (MultiSense® data and patient's questionnaire) | From patch placement to its removal (up to 7 days) |
| Respiratory rate accuracy in terms of impedance | Respiratory rate accuracy by comparison of MultiSense® data with the reference monitor in terms of impedance | From patch placement to hospital discharge, assessed up to 3 hours |
| Respiratory rate accuracy in terms of EtCO2 | Respiratory rate accuracy by comparison of MultiSense® data with the reference monitor in terms of EtCO2 | From patch placement to hospital discharge, assessed up to 3 hours |
| Estimation of posture and activity level reported by the MultiSense® solution | 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) | From patch placement to its removal (up to 7 days) |
| MultiSense® data quality after moderate level of activity | 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) | From patch placement to its removal (up to 7 days) |
| Correlation between body temperature and skin temperature | Correlation between the body temperature measured with a standard device and the skin temperature measured with the MultiSense® solution | From patch placement to hospital discharge, assessed up to 2 days |
| End of study hardware recovery rate | Percentage of MultiSense® patch and gateway returned to RDS at the end of the study | From patch removal to material return, assessed up to 1 month |