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

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
Philips Clinical & Medical Affairs Global
Study ID
NCT06895603
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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 Dates

Start date
Oct 28, 2025
Status verified
Feb 2026
Primary completion
Feb 28, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
75 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Primary Endpoints [ Time Frame: Approximately 8 months for accrual and follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UVA HealthCharlottesvilleVirginia22904-

Find similar trials in Charlottesville, VA

By research site
UVA Health· Charlottesville, VA

Related Studies