Use of RDS MultiSense® in Post-ICU Patients in the COVID-19 Era (MONIREA)

In this clinical study, the investigators will compare vital parameters measurements obtained using continuous data from reference monitors and continuous wireless MultiSense® monitoring patch in 60 post-ICU (Intensive Care Unit) patients and over 7 days.

Study Overview

• Status: Completed
• Conditions: Post ICU Rehabilitation
• Intervention / Treatment: Other: Remote Automated Monitoring System

Detailed Description

The MultiSense® strip is a unique, band aid-sized, clinical signal quality, connected strip for real-time monitoring of cardio-respiratory parameters. The MultiSense® strip measures in real-time, remotely and continuously 11 clinical key-indicators by being attached to the patient thorax: ECG trace, heart rate, oxygen saturation (SpO2), respiratory rate and relative respiration depth, pulse transit time, plethysmographic trace, perfusion index, skin temperature, physical activity and body position. Designed to be worn continuously for at least seven days, the patient can keep the patch during his sleep or in the shower.

The aim of this study is to determine the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of accuracy, connectivity, generation of artifactual data and stability of data transmission. The study population includes 60 patients transferred to post-ICU units for a minimum of 5 days. Once in the post-ICU unit, the MultiSense® strip will be attached on patient's thorax. The monitoring will last between 5 to 7 days.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • Anesthesia Department, Central Hospital
  • Strasbourg, France, 67000
    • Anesthesia, Critical Care & Perioperative Medicine, Hautepierre

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Man or woman over 18 years old.
• Patient previously cared in an ICU for severe COVID-19 pneumonia, COVID-related condition or similar neurological compromise necessitating post-ICU rehabilitation
• Negative respiratory SARS-CoV-2 (Severe Acute Respiratory Syndrome-Corona Virus-2) samples
• Patient admitted in a post-ICU rehabilitation unit with an expected length of stay > 5 days
• Patient able to receive and understand information related to the study and give written informed consent.

OR If the patient is not capable, presence of a next of kin able to receive and understand information related to the study and give written informed consent for the patient

• Patient authorizing the treatment of their personal data collected during the study (box checked in the consent form)
• Patient affiliated to the French social security system.

Exclusion Criteria:

• Patient with a skin disease that would preclude the use of an adhesive.
• Patient with an implantable device such as a pacemaker
• 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.

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: Remote Automated Monitoring System; MultiSense® strip will be attached on patient's thorax. The monitoring will last between 5 and 7 days during the post-ICU hospitalization, at rest and during rehabilitation exercises.	Other: Remote Automated Monitoring System; The patient will be monitored with conventional monitoring devices as well as the MultiSense patch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of accuracy.	Accuracy is defined as an average measurement variation less than 3.5 percent or 5 percent of the mean value, depending on the variable with respect to the reference standard.	from patch placement to hospital discharge, assessed up to 7 days
Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of connectivity.	Connectivity is defined as a time-wise ratio of missing versus total signal less than 20 percent.	from patch placement to hospital discharge, assessed up to 7 days
Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of generation of artifactual data.	The generation of artefact data is defined as a percentage of outlier data less than 10 percent.	from patch placement to hospital discharge, assessed up to 7 days
Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of stability of data transmission.	Data transmission stability is defined as a data transmission rate equal to or greater than 80 percent.	from patch placement to hospital discharge, assessed up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of a data acquisition patch by health care providers (HCPs) in the setting of post-ICU, rehabilitation unit assessed via a questionnaire.	Descriptive determination of user-friendliness, comprehensibility and ease of placement, connection and removal of the data acquisition patch by healthcare providers.	At hospital discharge, up to 7 days after the patch placement
User experience of post-ICU rehabilitation patients with the continuous use of the adhesive data acquisition patch during remote monitoring assessed via a patient's final questionnaire.	Descriptive determination of user experience and practicalities associated with wearing the data acquisition patch (e.g. portability, duration of skin adhesion, anticipated detachment, interference with activities and stigma perception).	At hospital discharge, up to 7 days after the patch placement
Assess patients' tolerability to prolonged use of an adhesive patch during remote monitoring.	Number of unexpected local and distant events attributable to the use of the adhesive data acquisition patch	From patch placement to its removal (up to 7 days)
Assess the correlation between body temperature and skin temperature	Correlation between the body temperature measured with a standard device and the skin temperature measured with the remote data acquisition device.	From patch placement to its removal (up to 7 days)
Assess the ability of the patch to detect and signal the clinically confirmed excursions of heart rate (high and low) outside predefined thresholds	Non-inferiority of the number of clinically confirmed alerts observed with the patch compared to those signalled by the conventional devices, and difference in the number of false positive excursions.	From patch placement to its removal (up to 7 days)
Assess the ability of the patch to detect and signal the clinically confirmed excursions of SpO2 (low) outside predefined thresholds	Non-inferiority of the number of clinically confirmed alerts observed with the patch compared to those signalled by the conventional devices, and difference in the number of false positive excursions.	From patch placement to its removal (up to 7 days)
Assess the ability of the patch to detect and signal the clinically confirmed excursions of respiratory rate (high and low) outside predefined thresholds	Non-inferiority of the number of clinically confirmed alerts observed with the patch compared to those signalled by the conventional devices, and difference in the number of false positive excursions.	From patch placement to its removal (up to 7 days)

Collaborators and Investigators

• Sponsor: IHU Strasbourg
• Collaborators: Rhythm Diagnostic Systems
• Investigators: Principal Investigator: Julien POTTECHER, MD, PhD, Anesthesia, Critical Care & Perioperative Medicine, Hautepierre, Strasbourg, France

Publications and helpful links

General Publications

• Pamuk K, Turan N. The effect of light on sleep quality and physiological parameters in patients in the intensive care unit. Appl Nurs Res. 2022 Aug;66:151607. doi: 10.1016/j.apnr.2022.151607. Epub 2022 Jun 26.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2021
• Primary Completion (Actual): March 2, 2025
• Study Completion (Actual): March 2, 2025

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Vital signs; Connected device; real-time monitoring; post-ICU; cardio-respiratory monitoring
• Other Study ID Numbers: 20-004

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
• product manufactured in and exported from the U.S.: No