Ireland
--:--IST
Recruiting Observational

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

NCT06895603 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2025-10-28
Last updated
2026-02-27

Condition(s) studied

ICUPulmonary Artery Catheter (PAC)Swan-Ganz Catheter

Investigational drug(s) / intervention(s)

Philips Advanced Monitoring Cuff (AMC)

Philips Advanced Monitoring Cuff (AMC): The Philips AMC is a Class II (USA) and Class IIb (EU) medical device that is a non-invasive, semirigid disposable upper arm cuff with an integrated pneumatic actuator enabling hydraulic coupling of tissue pressure waveforms from the upper arm tissue.

Study summary

The purpose of this study is to compare cardiac output (CO), fluid responsiveness, and related measurements between the Philips AMC and PAC (Swan-Ganz) in ICU or surgical patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adults aged 18 years and older * Indication for PAC (Swan-Ganz) * Indication for radial arterial line * Subject or legal authorized representative is able to understand and speak the local language (also Spanish is also accepted for US sites) to provide voluntary written informed consent prior to study procedures Exclusion Criteria: * Emergency surgery * ICU or surgical positioning where both arms are tucked * Inability to place the Philips AMC appropriately due to subject anatomy or condition * Known pregnancy or lactating women (self-report) * Patients treated with an intra-aortic balloon pump * Measurements taken in the lateral position * Currently participating in an investigational drug or another device study that clinically interferes with the study endpoints * Upper arm circumference \< 19 cm or \> 43 cm * BMI \> 45 * At the PI's discretion, subject does not qualify to participate in the study for any reasons that are not mentioned above

Primary outcome measure(s)

  • Primary Endpoints — Approximately 8 months for accrual and follow-up
    The comparison of cardiac output between the Philips AMC and PAC

Trial sites (2)

FacilityCityRegionStatus
UVA Health Charlottesville Virginia Recruiting
Universitätsklinikum Hamburg Eppendorf Hamburg Free and Hanseatic City of Hamburg Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06895603 on ClinicalTrials.gov ↗ ← All trials in the USA