Clinical trial NCT04661423: Use of RDS MultiSense® in Post-ICU Patients in the COVID-19 Era
Official title: Use of RDS MultiSense® in Post-ICU Patients in the COVID-19 Era
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post ICU Rehabilitation
Keywords: Vital signs
Connected device
real-time monitoring
post-ICU
cardio-respiratory monitoring
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
Collaborators: name: Rhythm Diagnostic Systems
First posted: 2020-12-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: from patch placement to hospital discharge, assessed up to 7 days
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 connectivity.
timeFrame: from patch placement to hospital discharge, assessed up to 7 days
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 generation of artifactual data.
timeFrame: from patch placement to hospital discharge, assessed up to 7 days
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 stability of data transmission.
timeFrame: from patch placement to hospital discharge, assessed up to 7 days
Secondary outcomes:
measure: Usability of a data acquisition patch by health care providers (HCPs) in the setting of post-ICU, rehabilitation unit assessed via a questionnaire.
timeFrame: At hospital discharge, up to 7 days after the patch placement
measure: 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.
timeFrame: At hospital discharge, up to 7 days after the patch placement
measure: Assess patients' tolerability to prolonged use of an adhesive patch during remote monitoring.
timeFrame: From patch placement to its removal (up to 7 days)
measure: Assess the correlation between body temperature and skin temperature
timeFrame: From patch placement to its removal (up to 7 days)
measure: Assess the ability of the patch to detect and signal the clinically confirmed excursions of heart rate (high and low) outside predefined thresholds
timeFrame: From patch placement to its removal (up to 7 days)
measure: Assess the ability of the patch to detect and signal the clinically confirmed excursions of SpO2 (low) outside predefined thresholds
timeFrame: From patch placement to its removal (up to 7 days)
measure: Assess the ability of the patch to detect and signal the clinically confirmed excursions of respiratory rate (high and low) outside predefined thresholds
timeFrame: From patch placement to its removal (up to 7 days)
Other outcomes:
Locations:
city: Nancy
country: France
facility: Anesthesia Department, Central Hospital
city: Strasbourg
country: France
facility: Anesthesia, Critical Care & Perioperative Medicine, Hautepierre
Study officials:
affiliation: Anesthesia, Critical Care & Perioperative Medicine, Hautepierre, Strasbourg, France
name: Julien POTTECHER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.