Philips IntelliVue X3 for Critical Illness

Recruiting at 3 trial locations

Overseen By Shakun Karki

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Philips Clinical & Medical Affairs Global

Disqualifiers: Pregnancy, Lactating, Aortic regurgitation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

189 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods of measuring blood pressure in critical care patients: a non-invasive cuff and a direct method using a tiny tube in an artery. The focus is on the accuracy of the Philips IntelliVue X3 Patient Monitor. Participants are divided into three groups: young children under 3, children aged 3 to 12, and those over 12, including adults. Ideal participants are those in intensive care who require both a blood pressure cuff and a radial arterial line (a small tube placed in the wrist artery). As an unphased trial, this study allows participants to contribute to advancements in critical care monitoring technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Philips IntelliVue X3 Patient Monitor is safe for measuring blood pressure in critical care patients?

Research has shown that the Philips IntelliVue X3 Patient Monitor is safe to use. It meets key safety standards set by the Medical Device Directive, 93/42/EEC, ensuring strict adherence to safety rules. The FDA considers this monitor similar to other approved devices, indicating effective performance in practice.

No major negative effects have been reported for the IntelliVue X3. Its design includes a smartphone-like interface and customizable screens, enhancing ease of use. This user-friendly design supports accurate and reliable readings.

Overall, compliance with safety standards and approval by regulatory bodies confirm the IntelliVue X3's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Philips IntelliVue X3 Patient Monitor because it represents a significant advancement in non-invasive blood pressure (NIBP) monitoring technology. Unlike traditional monitors that might be less adaptable across different age groups, this device is designed to accurately measure blood pressure in a wide range of patients, from neonates to adults. Its portability and advanced algorithms potentially allow for more precise and consistent readings, which could improve patient outcomes by providing better real-time data for healthcare providers. This trial aims to validate these features, potentially setting a new standard in patient monitoring.

What evidence suggests that the Philips IntelliVue X3 Patient Monitor is effective for measuring blood pressure in critical care patients?

Research has shown that the Philips IntelliVue X3 Patient Monitor provides accurate and reliable blood pressure readings. Studies have found that it integrates well with other patient monitoring systems, enabling doctors to make quick and effective decisions at the patient's side, thereby improving care. The device continuously monitors patients, which is crucial for those in critical care. Although specific data does not compare it directly to invasive methods like the radial arterial line, the system simplifies care and supports medical workflows. Its design reduces steps and enhances efficiency in patient monitoring, making it a promising tool in critical care settings. ^{1 3 6 7 8}

Who Is on the Research Team?

Amir Abdolahi

Principal Investigator

Philips Healthcare

Are You a Good Fit for This Trial?

Inclusion Criteria

You have been admitted to one of NICU, PICU, or ICU.

Three or more patients must weigh over 2000g.

The remaining patients may be from any age or weight group to fulfill the sample size.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Main Phase

Participants are monitored using the Philips NIBP system and radial arterial line to collect data points for validation

Approximately 1 year

Follow-up

Participants are monitored for safety and effectiveness after data collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Philips IntelliVue X3 Patient Monitor

How Is the Trial Designed?

Group I: Subject Group 3 Experimental Treatment 1 Intervention

Adolescent/Adult \>12 years of age

Group II: Subject Group 2 Experimental Treatment 1 Intervention

Children 3-12 years of age

Group III: Subject Group 1 Experimental Treatment 1 Intervention

Neonates, Infant, Children \<3 years of age

Who Is Running the Clinical Trial?

Philips Clinical & Medical Affairs Global

Lead Sponsor

Trials

61

Recruited

17,600+

Roy Jakobs

Philips Clinical & Medical Affairs Global

Chief Executive Officer since 2022

MBA from Erasmus University Rotterdam

Carla Goulart Peron

Philips Clinical & Medical Affairs Global

Chief Medical Officer since 2023

MD from an unspecified institution

Citations

1. usa.philips.com usa.philips.com/healthcare/enterprise-solutions/x3-workflow-patient-centered-monitoring

X3 patient-centered monitoring workflow Start and maintain continuous, patient-centered monitoring with IntelliVue X3—streamline care and support clinical workflows.

2. usa.philips.com usa.philips.com/healthcare/brand/intellivue-patient-monitors

IntelliVue Patient Monitors Philips IntelliVue patient monitors bring together critical components to aid effective clinical decision-making at the patient's side.

3. usa.philips.com usa.philips.com/healthcare/product/HC722463/hemo-with-intellivue-x3

Hemo with IntelliVue X3 Integration with the IntelliVue X3 patient monitor helps to enable confident clinical decision making and gap-free patient medical records, continuously ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K230604.pdf

November 22, 2023 Philips Medizin Systeme Boeblingen ... The X3 can be used in two ways: as a multi-measurement module for the Philips IntelliVue family of patient monitors and as a stand-alone monitor ...

5. usa.philips.com usa.philips.com/healthcare/product/HC867030/intellivue-x3-patient-monitor

IntelliVue X3 transport patient monitor IntelliVue X3 helps to streamline workflow and boost efficiency by reducing the number of steps to prepare patients for transport. Connected to an IntelliVue ...

6. images.philips.com images.philips.com/is/content/PhilipsConsumer/Campaigns/HC20182709_surgery_solutions/TDS_IntelliVue_X3_Patient_Monitor_RelM0indd.pdf

IntelliVue X3 Patient Monitor_Rel.M.0.indd For measurement extensions, see the respective Data Sheets. Safety Specifications. The monitor complies with the Medical Device Directive. 93/42/EEC and, among ...

7. documents.philips.com documents.philips.com/assets/Instruction%20for%20Use/20220525/7b8095318b244be7a5abaea000beb69b.pdf?feed=ifu_docs_feed

IntelliVue Patient Monitor - MX100/X3 ... monitor's display, such as measurements, alarms, patient data and so forth. ... Safety Information. The following warnings apply to the monitors in general.

8. philips.ie philips.ie/healthcare/product/HC867030/intellivue-x3-patient-monitor

IntelliVue X3 transport patient monitor The IntelliVue X3 is a compact, dual-purpose transport monitor with smartphone-style operation, customizable screens, and can act as a multi-measurement module.