RecruitingNot ApplicableNCT07052123

Non-Invasive Blood Pressure Monitoring in ICU Patients Using the DARE Device

Sponsor

Centre Hospitalier de Saint-Denis

Enrollment

2 participants

Start Date

Mar 24, 2025

Study Type

INTERVENTIONAL

Conditions

Critical Illness Hemodynamics Blood Pressure Monitoring Intensive Care Units Monitoring, Physiologic

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria9

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

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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.