HemodynamicsNCT07052123
Non-Invasive Blood Pressure Monitoring in ICU Patients Using the DARE Device
A study testing MultiSense® Non-Invasive Hemodynamic Monitoring Device in people with Hemodynamics and Blood Pressure Monitoring, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamics, Blood Pressure Monitoring, Intensive Care Units
- What is being tested?
- MultiSense® Non-Invasive Hemodynamic Monitoring Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 24 Mar 2025to 24 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
France
Saint-Denis, France
Daniel DA SILVA, +33142356140, coordination.rechercheclinique@ghtpdfr.fr
About this study
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.
- Conditions
- Hemodynamics, Blood Pressure Monitoring, Intensive Care Units, Critical Illness, Monitoring, Physiologic
- Being tested
- MultiSense® Non-Invasive Hemodynamic Monitoring Device
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultiSense® Non-Invasive Hemodynamic Monitoring DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MultiSense® Non-Invasive Hemodynamic Monitoring Arm | Experimental | Not described Receives: Device: MultiSense® Non-Invasive Hemodynamic Monitoring Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: Agreement between non-invasive blood pressure index (IPA) from MultiSense® and invasive blood pressure (PAI) from ICU monitors.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start24 Mar 2025
- Primary completion24 Mar 2028 (estimated)
- Study completion24 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodynamicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052123
- Sponsor's protocol ID
- 0060_DARE
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Blood Pressure Monitoring in ICU Patients Using the DARE Device
- ClinicalTrials.gov ID
- NCT07052123
- Acronym / sponsor ID
- 0060_DARE
- Conditions
- Hemodynamics, Blood Pressure Monitoring, Intensive Care Units, Critical Illness, Monitoring, Physiologic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 24 Mar 2028 (estimated)
- Study completion
- 24 Mar 2028 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MultiSense® Non-Invasive Hemodynamic Monitoring Arm | Experimental | Device: MultiSense® Non-Invasive Hemodynamic Monitoring Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MultiSense® Non-Invasive Hemodynamic Monitoring DeviceThe 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. | Device | MultiSense® Non-Invasive Hemodynamic Monitoring Arm |
Primary outcome
Primary outcome: Agreement between non-invasive blood pressure index (IPA) from MultiSense® and invasive blood pressure (PAI) from ICU monitors.
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MultiSense® Non-Invasive Hemodynamic Monitoring Device in people with Hemodynamics and Blood Pressure Monitoring, run by Centre Hospitalier de Saint-Denis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome: Agreement between non-invasive blood pressure index (IPA) from MultiSense® and invasive blood pressure (PAI) from ICU monitors. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.