NIBP Validation Study

Critical Illness Clinical Trial

Official title:

Non-Invasive Blood Pressure Validation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05673408
• Other study ID #: CC_MA_NIBPValidation_2022_1151
• Status: Recruiting
• Start date: June 23, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Philips Clinical & Medical Affairs Global
• Contact: Natalie Hernandez, MBA
• Phone: 210-517-4405
• Email: natalie.hernandez[@]philips.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to compare measurements of blood pressure (BP) between the Philips non-invasive blood pressure (NIBP) system (including NIBP cuff and portable patient monitor) and invasive radial arterial line (A-line) in critical care patients.

Description:

This is a multicenter, multi-phase, prospective, non-randomized, self-controlled, observational study to evaluate the validity of Philips non-invasive blood pressure technology.

This study is designed for the purpose of establishing equivalence of the Philips NIBP system with the gold standard arterial line.

Main Phase will be considered complete when the number of pre-defined subjects and data points are achieved per subject group.

• Subject Group 1: Neonates, Infant, Children <3 years of age Minimum of 24 subjects and 180 data points

• Subject Group 2: children 3-12 years of age Minimum of 41 subjects and 205 data points

• Subject Group 3: Adolescent/Adult >12 years of age Minimum of 124 subjects and 620 data points

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 189
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient admitted into the Neonatal Intensive Care Unit (NICU), Pediatric Intensive Care Unit (PICU), or Intensive Care Unit (ICU)

• Adult aged 18 years and older, or parent/legal guardian of minor, willing and able to understand and provide informed consent/assent

• Indication for NIBP cuff

• Indication for radial arterial line

Exclusion Criteria:

• Inability to place the study device appropriately due to patient's anatomy or condition

• Known pregnancy or lactating women (self-report)

• Patients treated with an intra-aortic balloon pump

• Aortic and mitral regurgitation (> 2nd degree)

• Measurements taken in the lateral position

• Currently participating in another clinical trial with any product, treatment and/or medication that clinically interferes with the study endpoint(s)

• Currently receiving vasopressors during data collection

• If valid SBP reference measurements for lateral difference is > 15 mmHg

• If valid DBP reference measurements for lateral difference is > 10 mmHg

• At the Principal Investigator's discretion, subject does not qualify to participate in the study for any reasons that are not mentioned above

Related Conditions & MeSH terms

• Critical Illness

Intervention

Device:
• Philips IntelliVue X3 Patient Monitor
All subjects enrolled in this study will receive one Philips non-invasive blood pressure cuff. This cuff will be connected via compatible hose to the Philips IntelliVue X3 monitor hosting the released or investigational NIBP algorithm. The invasive blood pressure from the radial arterial line will also be connected to the Philips IntelliVue X3 monitor. The Philips IntelliVue X3 monitor will in turn be connected to a laptop for data collection.

Locations

Country	Name	City	State
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Philips NIBP System Equivalence to Radial Arterial Line	The primary endpoint is the accuracy and precision of systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) measured by the Philips NIBP system (including NIBP cuff and portable patient monitor) in comparison to radial arterial line.	Through study completion, approximately 1 year