Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07052123

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

Led by Centre Hospitalier de Saint-Denis · Updated on 2025-07-04

2

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new non-invasive device called MultiSense® designed to monitor blood pressure and other vital signs in intensive care unit (ICU) patients. This study compares the device's readings with standard invasive methods to assess accuracy. The goal is to improve patient safety and comfort while helping doctors detect issues earlier by monitoring blood pressure, microcirculation, central body temperature, and heart rhythm. The study involves using the MultiSense® device, a wireless system applied to ICU patients who already have invasive catheters for blood pressure and temperature monitoring. The device continuously collects vital sign data and uses intelligent algorithms to reduce false alarms and enhance patient mobility. The study is non-randomized and does not involve placebo or masking. Participants will be adult ICU patients expected to stay more than two days and equipped with arterial and urinary catheters. Researchers will monitor agreement between the non-invasive blood pressure readings from MultiSense® and invasive measurements over seven days. Safety, comfort, and data accuracy will be evaluated through continuous monitoring during the ICU stay. The study lasts from March 2025 to March 2028.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 7 days

Participants have the MultiSense® non-invasive hemodynamic monitoring device applied to continuously measure blood pressure, microcirculation, central body temperature, and detect arrhythmias while in the ICU.

Continuous monitoring during ICU stay

Trial Site Locations

Total: 1 location

1

France

Saint-Denis, France, France

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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