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

Recruiting now

Conditions studied: ICU, Pulmonary Artery Catheter (PAC), Swan-Ganz Catheter

In brief

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.

Key facts

Study ID: NCT06895603
Run by: Philips Clinical & Medical Affairs Global
People needed: 75
Starts: 2025-10-28
Expected to finish: 2026-06-01
Last updated by the study team: 2026-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

UVA Health — Charlottesville, Virginia, United States (enrolling)
Universitätsklinikum Hamburg Eppendorf — Hamburg, Free and Hanseatic City of Hamburg, Germany (enrolling)

Full record on ClinicalTrials.gov

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