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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier de Saint-Denis

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

2 Participants
are divided into 1 treatment group
Group A: MultiSense® Non-Invasive Hemodynamic Monitoring ArmExperimental treatment 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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