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

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.

Study Overview

• Status: Completed
• Conditions: Visceral and Digestive Surgery; Post-surgical Monitoring; Post-surgical Rehabilitation
• Intervention / Treatment: Device: MultiSense® remote monitoring

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67000
    • Service de Chirurgie Digestive et Endocrinienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: MultiSense® remote monitoring; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: IHU Strasbourg
• Collaborators: Rhythm Diagnostic Systems
• Investigators: Principal Investigator: Michel VIX, MD, Service de Chirurgie Digestive, NHC, HUS

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2022
• Primary Completion (Actual): September 2, 2022
• Study Completion (Actual): September 2, 2022

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: telemonitoring; Vital signs; Connected device; real-time monitoring; cardio-respiratory monitoring; post-surgery monitoring
• Other Study ID Numbers: 21-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No