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

NCT07052123 | Recruiting

• 1 other identifier: 0060_DARE
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  7 days

Study Arms (1)

MultiSense® Non-Invasive Hemodynamic Monitoring Arm

EXPERIMENTAL

Device: MultiSense® Non-Invasive Hemodynamic Monitoring Device

Interventions

MultiSense® Non-Invasive Hemodynamic Monitoring Device 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.

MultiSense® Non-Invasive Hemodynamic Monitoring Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Saint-Denis: lead

Study Sites (1)

France

Saint-Denis, France, France

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: July 4, 2025
• Study Start: March 24, 2025
• Primary Completion (Estimated): March 24, 2028
• Study Completion (Estimated): March 24, 2028
• Last Updated: July 4, 2025

Record last verified: 2025-06

Locations

FR (1)