NIBP Validation Study

Status Recruiting

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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Critical Illness

Clinical Trial Details

NCT number	NCT05673408
Study type	Observational
Source	Philips Clinical & Medical Affairs Global
Contact	Natalie Hernandez, MBA
Phone	210-517-4405
Email	natalie.hernandez@philips.com
Status	Recruiting
Phase
Start date	June 23, 2023
Completion date	December 31, 2024

View Details

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