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

Centre Hospitalier de Saint-Denis2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

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

Interventions

MultiSense® Non-Invasive Hemodynamic Monitoring DeviceDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Primary outcome: Agreement between non-invasive blood pressure index (IPA) from MultiSense® and invasive blood pressure (PAI) from ICU monitors.

Time frame: 7 days