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

NCT05357729 | Completed

• 1 other identifier: 21-004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (13)

• 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)

• Device defects

  From patch placement to its removal (up to 7 days)

• Clinical relevance of the notifications provided by MultiSense® solution

  From patch placement to its removal (up to 7 days)

• Clinical relevance of the notifications provided by MultiSense® solution

  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

  From patch placement to its removal (up to 7 days)

Study Arms (1)

MultiSense® remote monitoring

EXPERIMENTAL

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

Interventions

MultiSense® remote monitoring DEVICE

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.

MultiSense® remote monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 under guardianship or trusteeship
• Patient under the protection of justice or deprived of liberty
• Patient in situation of emergency

Sponsors & Collaborators

• IHU Strasbourg: lead
• Rhythm Diagnostic Systems: collaborator

Study Sites (1)

Service de Chirurgie Digestive et Endocrinienne

Strasbourg, 67000, France

Location

Study Officials

• Michel VIX, MD

  Service de Chirurgie Digestive, NHC, HUS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 3, 2022
• Study Start: June 14, 2022
• Primary Completion: September 2, 2022
• Study Completion: September 2, 2022
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)