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

IHU Strasbourg

Status: Completed

Conditions: Post ICU Rehabilitation

Treatments: Other: Remote Automated Monitoring System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04661423

20-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Remote Automated Monitoring System

Experimental group

Description:

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.

Treatment:

Other: Remote Automated Monitoring System