NCT05673408

NIBP Validation Study

Non-Invasive Blood Pressure Validation Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 189 (estimated)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 for Subject Group 2 and 3, and radial or umbilical arterial line for neonates (A-line) in critical care patients.

Detailed description

A multi-center, multi-phase, prospective, self-controlled, observational study. * Phase I - A pilot phase designed for feasibility and the potential for algorithm development (enhancement). * Phase II - Pivotal Phase: At the completion of Phase I -and finalization of the algorithm (if applicable), Phase II is designed for the purpose of establishing equivalence of the Philips NIBP system with the gold standard radial or umbilical (neonates) arterial line.

Conditions

• Critical Illness

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-23
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-01-06
• Last updated: 2025-12-09

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study