Blood Pressure Monitoring, Critical Illness, Hemodynamics, Intensive Care Units, Monitoring, Physiologic
Conditions
Brief summary
This study tests a new non-invasive device called DARE to monitor blood pressure in patients in intensive care. It compares the device's readings to standard invasive methods and also looks at how well it measures other vital signs like temperature, oxygen levels, and heart rhythm. The goal is to improve patient safety and comfort while helping doctors detect problems earlier.
Interventions
DEVICEMultiSense® Non-Invasive Hemodynamic Monitoring Device
The MultiSense® device is a wireless, non-invasive monitoring system designed to continuously measure blood pressure, microcirculation, central body temperature, and detect arrhythmias in ICU patients. It aims to reduce risks associated with invasive monitoring, improve patient comfort and mobility, and decrease alarm fatigue through intelligent alert algorithms.
Sponsors
Centre Hospitalier de Saint-Denis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (male or female), aged 18 years or older * Admitted to intensive care unit (ICU) or critical care with an expected hospital stay longer than 2 days * Equipped with an arterial catheter for invasive blood pressure monitoring * Equipped with a urinary catheter for invasive core body temperature monitoring
Exclusion criteria
* Patients under 18 years old (minors) * Known skin allergy to adhesives or silicone, or skin condition preventing adhesive use * History of extensive skin pathology (e.g., Lyell syndrome) * Patients with therapeutic limitations * Patients with active implanted medical devices (e.g., pacemaker, defibrillator) * Pregnant or breastfeeding women * Patients not affiliated with the French social security system * Patients or their legal representatives refusing consent, or unable to understand information and give informed consent * Patients under legal guardianship, curatorship, or deprived of liberty
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: Agreement between non-invasive blood pressure index (IPA) from MultiSense® and invasive blood pressure (PAI) from ICU monitors. | 7 days |
Countries
France
Outcome results
None listed