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

NCT04661423 | Completed

• 1 other identifier: 20-004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Post ICU Rehabilitation

Keywords

Vital signs; Connected device; real-time monitoring; post-ICU; cardio-respiratory monitoring

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

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

  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.

  At hospital discharge, up to 7 days after the patch placement

• Assess patients' tolerability to prolonged use of an adhesive patch during remote monitoring.

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

• Assess the correlation between body temperature and skin temperature

  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

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

Study Arms (1)

Remote Automated Monitoring System

EXPERIMENTAL

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

Interventions

Remote Automated Monitoring System OTHER

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

Remote Automated Monitoring System

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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 under guardianship or trusteeship.
• Patient under the protection of justice.

Sponsors & Collaborators

• IHU Strasbourg: lead
• Rhythm Diagnostic Systems: collaborator

Study Sites (2)

Anesthesia Department, Central Hospital

Nancy, 54000, France

Location

Anesthesia, Critical Care & Perioperative Medicine, Hautepierre

Strasbourg, 67000, France

Location

Related Publications (1)

• 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.

  PMID: 35840273 DERIVED

Study Officials

• Julien POTTECHER, MD, PhD

  Anesthesia, Critical Care & Perioperative Medicine, Hautepierre, Strasbourg, France

  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: December 7, 2020
• First Posted: December 10, 2020
• Study Start: September 2, 2021
• Primary Completion: March 2, 2025
• Study Completion: March 2, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)