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

IHU Strasbourg60 enrolled

Overview

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.

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Post ICU Rehabilitation

Interventions

Remote Automated Monitoring SystemOTHER

The patient will be monitored with conventional monitoring devices as well as the MultiSense patch.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Anesthesia Department, Central Hospital

Nancy, France

Anesthesia, Critical Care & Perioperative Medicine, Hautepierre

Strasbourg, France

Outcomes

Primary Outcomes

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.

Time frame: from patch placement to hospital discharge, assessed up to 7 days

Connectivity is defined as a time-wise ratio of missing versus total signal less than 20 percent.

Time frame: from patch placement to hospital discharge, assessed up to 7 days

The generation of artefact data is defined as a percentage of outlier data less than 10 percent.

Time frame: from patch placement to hospital discharge, assessed up to 7 days

Data transmission stability is defined as a data transmission rate equal to or greater than 80 percent.

Time frame: from patch placement to hospital discharge, assessed up to 7 days

Secondary Outcomes

Usability of a data acquisition patch by health care providers (HCPs) in the setting of post-ICU, rehabilitation unit assessed via a questionnaire.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.