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Recruiting NCT07052123

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

No phase Interventional Hemodynamics Blood Pressure Monitoring Intensive Care Units Critical Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MultiSense® Non-Invasive Hemodynamic Monitoring Device.
Who it may be relevant to
Registry conditions: Hemodynamics, Blood Pressure Monitoring, Intensive Care Units, Critical Illness. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Interventions

  • Device MultiSense® 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.

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

France · 1 center
  • France — Saint-Denis

Identifiers

NCT: NCT07052123 · 0060_DARE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗