Non-Invasive Blood Pressure Monitoring in ICU Patients Us... | NCT07052123

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

NCT07052123

Sponsor

Centre Hospitalier de Saint-Denis

Status

Recruiting

Last Update Posted

Jul 4, 2025Actual

Enrollment

2Estimated

Phase

Not Applicable

Conditions

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

Interventions

MultiSense® Non-Invasive Hemodynamic Monitoring Device

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 24, 2025Actual

Primary Completion Date

Mar 24, 2028Estimated

Completion Date

Mar 24, 2028Estimated

First Submitted Date

Jun 5, 2025

First Submission Date that Met QC Criteria

Jun 26, 2025

First Posted Date

Jul 4, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2025

Last Update Posted Date

Jul 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. The goal is to improve patient safety and comfort while helping doctors detect problems earlier.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MultiSense® Non-Invasive Hemodynamic Monitoring Arm	Experimental		Device: MultiSense® Non-Invasive Hemodynamic Monitoring Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary outcome: Agreement between non-invasive blood pressure index (IPA) from MultiSense® and invasive blood pressure (PAI) from ICU monitors.		7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
France	Recruiting	Saint-Denis	France		France

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided