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NCT Number: NCT07052123

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

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.

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Key information

Conditions

Hemodynamics Blood Pressure Monitoring Critical Illness Disease Attributes Intensive Care Units Monitoring, Physiologic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Saint-Denis

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 4, 2025
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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