Non-invasive blood pressure monitoring in ICU with the DARE device
Non-Invasive Blood Pressure Monitoring in ICU Patients Using the DARE Device
This study tests whether the DARE non-invasive monitor can reliably measure blood pressure and other vital signs in adults in the ICU who have invasive arterial and urinary catheters.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier de Saint-Denis Academic / other |
| Locations | 1 site (Saint-Denis, France) |
| Trial ID | NCT07052123 on ClinicalTrials.gov |
What this trial studies
The trial compares continuous readings from the DARE (MultiSense®) non-invasive hemodynamic monitor with standard invasive arterial pressure and urinary core temperature measurements in adult ICU patients. It records additional signals such as pulse oximetry and cardiac rhythm to see how well the device tracks multiple vital signs. Eligible patients are adults expected to remain in the ICU for more than two days and already have arterial and urinary catheters in place; key exclusions include skin allergy to adhesives, active implanted devices, pregnancy, or legal incapacity to consent. The study is being conducted at Centre Hospitalier de Saint-Denis in France and collects paired invasive and non-invasive measurements for direct comparison.
Who should consider this trial
Good fit: Adults (18+) admitted to the ICU at the enrolling site who are expected to stay more than two days and already have an arterial catheter and urinary catheter are the ideal candidates.
Not a fit: Patients without the required invasive catheters, with adhesive or silicone skin allergies, active implanted devices, pregnant or breastfeeding women, minors, or those unable to consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the device could allow accurate, more comfortable hemodynamic monitoring without invasive arterial lines, reducing discomfort and potential catheter-related complications.
How similar studies have performed: Other non-invasive continuous hemodynamic monitors have shown promising but variable accuracy compared with invasive arterial lines, so the approach is partially supported by prior work but not yet universally validated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Saint-Denis, France
- France — Saint-Denis, France, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.