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

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.

Study Overview

• Status: Recruiting
• Conditions: ICU; Pulmonary Artery Catheter (PAC); Swan-Ganz Catheter
• Intervention / Treatment: Device: Philips Advanced Monitoring Cuff (AMC)

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Lea Egger; Phone Number: +49 172 2314 318; Email: lea.egger@philips.com

Study Locations

• Germany
  • Hamburg
    • Hamburg, Hamburg, Germany, 20246
      • Recruiting
      • Universitatsklinikum Hamburg Eppendorf
• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22904
      • Recruiting
      • UVA Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoints	The comparison of cardiac output between the Philips AMC and PAC	Approximately 8 months for accrual and follow-up

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HIPULSE-CO_PAC_2021_11366

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No