Clinical trial NCT05357729: Safety and Performance Study of the MultiSense® Ambulatory Telemonitoring System for Non-critical Patient Management
Official title: Safety and Performance Study of the MultiSense® Ambulatory Telemonitoring System for Non-critical Patient Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visceral and Digestive Surgery
Post-surgical Monitoring
Post-surgical Rehabilitation
Keywords: Vital signs
Connected device
real-time monitoring
post-surgery monitoring
cardio-respiratory monitoring
telemonitoring
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
Collaborators: name: Rhythm Diagnostic Systems
First posted: 2022-05-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: From patch placement to hospital discharge, assessed up to 3 hours
measure: Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of data availability.
timeFrame: From patch placement to removal, assessed up to 7 days
measure: Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of data artefacts.
timeFrame: From patch placement to removal, assessed up to 7 days
measure: Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of data transmission.
timeFrame: From patch placement to removal, assessed up to 7 days
Secondary outcomes:
measure: Patient's tolerance to prolonged use of the MultiSense® solution (Safety in use, side effects)
timeFrame: From patch placement to its removal (up to 7 days)
measure: Device defects
timeFrame: From patch placement to its removal (up to 7 days)
measure: Clinical relevance of the notifications provided by MultiSense® solution
timeFrame: From patch placement to its removal (up to 7 days)
measure: Clinical relevance of the notifications provided by MultiSense® solution
timeFrame: From patch placement to its removal (up to 7 days)
measure: Remote monitoring facilitation for the healthcare professional through the solution's ease of use and satisfaction gained
timeFrame: From patch placement to its removal (up to 7 days)
measure: Patient's satisfaction and reassurance when monitored by the device
timeFrame: From patch placement to its removal (up to 7 days)
measure: Patch autonomy
timeFrame: From patch placement to its removal (up to 7 days)
measure: Respiratory rate accuracy in terms of impedance
timeFrame: From patch placement to hospital discharge, assessed up to 3 hours
measure: Respiratory rate accuracy in terms of EtCO2
timeFrame: From patch placement to hospital discharge, assessed up to 3 hours
measure: Estimation of posture and activity level reported by the MultiSense® solution
timeFrame: From patch placement to its removal (up to 7 days)
measure: MultiSense® data quality after moderate level of activity
timeFrame: From patch placement to its removal (up to 7 days)
measure: Correlation between body temperature and skin temperature
timeFrame: From patch placement to hospital discharge, assessed up to 2 days
measure: End of study hardware recovery rate
timeFrame: From patch removal to material return, assessed up to 1 month
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive et Endocrinienne
Study officials:
affiliation: Service de Chirurgie Digestive, NHC, HUS
name: Michel VIX, MD
role: PRINCIPAL_INVESTIGATOR
References: