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

Sponsor

IHU Strasbourg (Other)

Overall Status

Recruiting

CT.gov ID

NCT05357729

Collaborator

RDS SAS (Rhythm Diagnostic Systems) (Other)

Enrollment

Location

Arm

11.6

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Visceral and Digestive Surgery Post-surgical Monitoring Post-surgical Rehabilitation	Device: MultiSense® remote monitoring	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jun 14, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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 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%.
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 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.

Secondary Outcome Measures

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
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
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 a questionnaire (4-levels Likert scale)
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)
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)
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
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
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)
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)
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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