Post ICU Rehabilitation Clinical Trial
— MONIREAOfficial title:
Use of RDS MultiSense® in Post-ICU Patients in the COVID-19 Era
| NCT number | NCT04661423 |
| Other study ID # | 20-004 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 2, 2021 |
| Est. completion date | February 2024 |
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | February 2024 |
| Est. primary completion date | February 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Anesthesia Department, Central Hospital | Nancy | |
| France | Anesthesia, Critical Care & Perioperative Medicine, Hautepierre | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| IHU Strasbourg | Rhythm Diagnostic Systems |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | 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. | At hospital discharge, up to 7 days after the patch placement | |
| Secondary | 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). | At hospital discharge, up to 7 days after the patch placement | |
| Secondary | 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 | From patch placement to its removal (up to 7 days) | |
| Secondary | 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. | From patch placement to its removal (up to 7 days) | |
| Secondary | 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. | From patch placement to its removal (up to 7 days) | |
| Secondary | 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. | From patch placement to its removal (up to 7 days) | |
| Secondary | 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. | From patch placement to its removal (up to 7 days) |