Safety and Performance Study of the MultiSense® Ambulatory Telemonitoring System for Non-critical Patient Management

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.

Inclusion criteria

• 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

Exclusion criteria

• 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