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

Visceral and Digestive Surgery Clinical Trial

— TELESENSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05357729
• Other study ID #: 21-004
• Status: Completed
• Phase: N/A
• Start date: June 14, 2022
• Est. completion date: September 2, 2022

Study information

• Verified date: January 2024
• Source: IHU Strasbourg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2, 2022
• Est. primary completion date: September 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Visceral and Digestive Surgery

Intervention

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.

Locations

Country	Name	City	State
France	Service de Chirurgie Digestive et Endocrinienne	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
IHU Strasbourg	Rhythm Diagnostic Systems

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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