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

RECRUITING

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

NCT06895603•Philips Clinical & Medical Affairs Global

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (2)

UVA Health

Charlottesville, Virginia, United States

Universitätsklinikum Hamburg Eppendorf

Hamburg, Hamburg, Germany

Key Dates

Start Date

October 28, 2025

Primary Completion Date

February 1, 2026

Completion Date

June 1, 2026

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

ICUPulmonary Artery Catheter (PAC)Swan-Ganz Catheter

Interventions

Philips Advanced Monitoring Cuff (AMC)

DEVICE

Contacts

Lea Egger

CONTACT

+49 172 2314 318 lea.egger@philips.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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