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

NCT06895603 | Recruiting FDA Device

• 1 other identifier: HIPULSE-CO_PAC_2021_11366
• Study Type: observational
• Target: 75
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

ICU; Pulmonary Artery Catheter (PAC); Swan-Ganz Catheter

Outcome Measures

Primary Outcomes (1)

• Primary Endpoints

  The comparison of cardiac output between the Philips AMC and PAC

  Approximately 8 months for accrual and follow-up

Study Arms (1)

All patients being monitored with a pulmonary artery catheter

Up to 75 intensive care unit patients being monitored with a pulmonary artery catheter (approximately 20 patients from at least 2 sites during the roll-in phase and approximately 55 patients during the pivotal phase) will be enrolled over an estimated 8 months accrual and follow-up evaluation period. There will be no randomization in this study.

Device: Philips Advanced Monitoring Cuff (AMC)

Interventions

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.

All patients being monitored with a pulmonary artery catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 75 ICU patients being monitored with a PAC and radial arterial line will be enrolled over approximately 8 months accrual and follow-up evaluation period

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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (2)

UVA Health

Charlottesville, Virginia, 22904, United States

RECRUITING

Universitätsklinikum Hamburg Eppendorf

Hamburg, Hamburg, 20246, Germany

RECRUITING

Central Study Contacts

Lea Egger

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: October 28, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); DE (1)