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

IHU Strasbourg20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Visceral and Digestive Surgery Post-surgical Monitoring Post-surgical Rehabilitation

Interventions

MultiSense® remote monitoringDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult (male or female over 18 years) in non-critical care settings 2. Patient programmed for an elective surgery 3. Need to monitor at home at least one physiological parameter: heart rate, respiratory rate, SpO2, temperature, physical activity 4. Patient able to use a smartphone 5. Patient with Wi-Fi and/or Cellular connectivity at home 6. Patient with a personal phone which allows to receive text messages 7. Patient able to receive and understand information related to the study and give written informed consent 8. Patient affiliated to the French social security system Exclusion Criteria: 1. Patient with known skin allergy (adhesive or silicon) or skin disease that would not allow the use of an adhesive 2. Patient with an active implantable device (such as a pacemaker or automatic defibrillator) 3. Patient with an elective imagery planned during the use of MultiSense 4. Pregnant or lactating patient 5. Patient in exclusion period (determined by a previous or a current study) 6. Patient under guardianship or trusteeship 7. Patient under the protection of justice or deprived of liberty 8. Patient in situation of emergency

Locations (1)

Service de Chirurgie Digestive et Endocrinienne

Strasbourg, France

Outcomes

Primary Outcomes

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

Time frame: 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%.

Time frame: 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.

Time frame: 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.

Time frame: From patch placement to removal, assessed up to 7 days

Secondary Outcomes

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

Time frame: From patch placement to its removal (up to 7 days)

Data from ClinicalTrials.gov

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