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

Not Applicable

Recruiting

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

• Registration Number: NCT07052123
• Lead Sponsor: Centre Hospitalier de Saint-Denis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-24
• Status Verified: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-06-26
• Study First Posted: 2025-07-04
• Last Update Posted: 2025-07-04
• Primary Completion: 2028-03-24
• Study Completion: 2028-03-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary outcome: Agreement between non-invasive blood pressure index (IPA) from MultiSense® and invasive blood pressure (PAI) from ICU monitors.	7 days

Trial Locations

Locations (1)

France; 🇫🇷 Saint-Denis, France