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Completed

NCT Number: NCT04661423

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

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.

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Key information

Conditions

Post ICU Rehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anesthesia Department, Central Hospital, Nancy, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote Automated Monitoring System

Other

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

Primary outcomes

  1. 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.

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

    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.

  2. 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.

    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.

  3. 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.

    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.

  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 stability of data transmission.

    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.

Secondary outcomes

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

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

    Descriptive determination of user-friendliness, comprehensibility and ease of placement, connection and removal of the data acquisition patch by healthcare providers.

  2. 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.

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

    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).

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

    Time frame: From patch placement to its removal (up to 7 days)

    Number of unexpected local and distant events attributable to the use of the adhesive data acquisition patch

  4. Assess the correlation between body temperature and skin temperature

    Time frame: From patch placement to its removal (up to 7 days)

    Correlation between the body temperature measured with a standard device and the skin temperature measured with the remote data acquisition device.

  5. Assess the ability of the patch to detect and signal the clinically confirmed excursions of heart rate (high and low) outside predefined thresholds

    Time frame: From patch placement to its removal (up to 7 days)

    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.

  6. Assess the ability of the patch to detect and signal the clinically confirmed excursions of SpO2 (low) outside predefined thresholds

    Time frame: From patch placement to its removal (up to 7 days)

    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.

  7. Assess the ability of the patch to detect and signal the clinically confirmed excursions of respiratory rate (high and low) outside predefined thresholds

    Time frame: From patch placement to its removal (up to 7 days)

    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.

Sponsors and collaborators

Lead sponsor

IHU Strasbourg

Other

Collaborators

  • Rhythm Diagnostic Systems

Registry information

Acronym: MONIREA

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2020
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.