NCT06895590

The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 205 (estimated)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare measurements of blood pressure (BP) and fluid responsiveness between the Philips AMC and invasive radial arterial line in surgical patients.

Detailed description

Primary Objective: • To evaluate equivalence of BP measurements (Systolic Blood Pressure \[SBP\], Diastolic Blood Pressure \[DBP\], and Mean Arterial Pressure \[MAP\]) derived from the Philips AMC to the radial arterial line as ground truth. Secondary Objectives: * To evaluate equivalence of Pulse Rate (PR) obtained by the Philips AMC to the radial arterial line as the ground truth. * To evaluate equivalence of Pulse Pressure Variation (PPV) obtained by the Philips AMC to calculated PPV obtained using the radial arterial line waveform pulse pressures as the ground truth. * To evaluate equivalence of Stroke Volume Variation (SVV) obtained by the Philips AMC to calculated SVV (e.g. from a predicate device that uses the radial arterial line waveform) as the ground truth. * To evaluate superiority of blood pressure measurements obtained by the Philips AMC to the oscillometric non-invasive blood pressure (NIBP) cuff, with the radial arterial line as the reference. * To evaluate trending agreement of BP and fluid responsiveness measurements. * To assess time to apply the Philips AMC relative to the radial arterial line. * To assess time from set-up start to first measurement completion between the Philips AMC and radial arterial line. * To collect and report safety data from the Philips AMC. * To collect and report system user experience and satisfaction scores from Philips AMC users. * To create a research dataset with the collected data to use for future hemodynamic algorithm development and validation. Hypothesis: Blood pressure measurements derived from the Philips AMC are equivalent to the radial arterial line and superior to the oscillometric non-invasive blood pressure (NIBP) cuff.

Conditions

• Non-cardiac Surgical
• Intensive Care Unit (ICU)

Interventions

Type	Name	Description
DEVICE	Philips Advanced Monitoring Cuff (i.e. AMC)	Investigational, non-invasive upper arm cuff

Timeline

• Start date: 2025-10-02
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2025-03-26
• Last updated: 2026-02-27

Locations

4 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated device study