Post ICU RehabilitationMONIREANCT04661423
Use of RDS MultiSense® in Post-ICU Patients in the COVID-19 Era
A study testing Remote Automated Monitoring System in people with Post ICU Rehabilitation, run by IHU Strasbourg at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post ICU Rehabilitation
- What is being tested?
- Remote Automated Monitoring System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Sep 2021to 2 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
France2 sites
Anesthesia Department, Central Hospital
Nancy, 54000
Anesthesia, Critical Care & Perioperative Medicine, Hautepierre
Strasbourg, 67000
About this study
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.
Read the 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.
- Conditions
- Post ICU Rehabilitation
- Being tested
- Remote Automated Monitoring System
- Keywords
- Vital signs, Connected device, real-time monitoring, post-ICU, cardio-respiratory monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Automated Monitoring SystemOther
The patient will be monitored with conventional monitoring devices as well as the MultiSense patch.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Remote Automated Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Descriptive determination of user-friendliness, comprehensibility and ease of placement, connection and removal of the data acquisition patch by healthcare providers.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From patch placement to its removal (up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start2 Sep 2021
- Primary completion2 Mar 2025
- Study completion2 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post ICU RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Collaborators
- Rhythm Diagnostic Systems
- Responsible party
- Sponsor
- Investigators
- Julien POTTECHER, MD, PhD, Principal investigator, Anesthesia, Critical Care & Perioperative Medicine, Hautepierre, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661423
- Sponsor's protocol ID
- 20-004
- Acronym
- MONIREA
- Status last verified
- Apr 2025
- First submitted
- 7 Dec 2020
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35840273
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of RDS MultiSense® in Post-ICU Patients in the COVID-19 Era
- ClinicalTrials.gov ID
- NCT04661423
- Acronym / sponsor ID
- MONIREA / 20-004
- Conditions
- Post ICU Rehabilitation
- Keywords
- Vital signs, Connected device, real-time monitoring, post-ICU, cardio-respiratory monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Collaborators
- Rhythm Diagnostic Systems
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 2 Mar 2025 (actual)
- Study completion
- 2 Mar 2025 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote Automated Monitoring System | Experimental | Other: Remote Automated Monitoring SystemMultiSense® 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Automated Monitoring SystemThe patient will be monitored with conventional monitoring devices as well as the MultiSense patch. | Other | Remote Automated Monitoring System |
Primary outcome
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.
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.
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.
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.
7 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.
Time frame: 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.
Time frame: At hospital discharge, up to 7 days after the patch placement
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)
Assess the correlation between body temperature and skin temperature
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From patch placement to its removal (up to 7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Derived from this study: PubMed 35840273Pamuk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien POTTECHER, MD, PhD principal investigator
Anesthesia, Critical Care & Perioperative Medicine, Hautepierre, Strasbourg, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Automated Monitoring System in people with Post ICU Rehabilitation, run by IHU Strasbourg at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04661423, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.