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

NCT ID: NCT07052123

Last Updated: 2025-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-24

Study Completion Date

2028-03-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemodynamics Blood Pressure Monitoring Intensive Care Units Critical Illness Monitoring, Physiologic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MultiSense® Non-Invasive Hemodynamic Monitoring Arm

Group Type EXPERIMENTAL

MultiSense® Non-Invasive Hemodynamic Monitoring Device

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier de Saint-Denis

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

France

Saint-Denis, France, France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Daniel DA SILVA

Role: primary

+33142356140

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0060_DARE

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Maternal Non-Stress Testing
NCT04343482 COMPLETED