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

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.

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Key information

Conditions

ICU Pulmonary Artery Catheter (PAC) Swan-Ganz Catheter

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Hamburg Eppendorf, Hamburg, Free and Hanseatic City of Hamburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Philips Advanced Monitoring Cuff (AMC)

Device

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.

Primary outcomes

Primary Endpoints

Time frame: Approximately 8 months for accrual and follow-up

The comparison of cardiac output between the Philips AMC and PAC

Study contacts

Contact information is provided by the study sponsor or research team.

Lea Egger

CONTACT

[email protected]

+49 172 2314 318

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Registry information

Acronym: CO

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Mar 26, 2025
Registry last updated: Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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