Recruiting

Philips AMC vs. PAC

Sponsor:

Philips Clinical & Medical Affairs Global

Code:

NCT06895603

Conditions

ICU

Pulmonary Artery Catheter (PAC)

Swan-Ganz Catheter

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Philips Advanced Monitoring Cuff (AMC)

Study Details

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

Study ID

NCT06895603

Start date

Oct 28, 2025

Status verified date

Feb, 2026

Completion date

Jun, 2026

Anticipated

Primary completion date

Feb, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Lea Egger

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

Locations

UVA Health

Recruiting

Charlottesville, Virginia, United States, 22904

More Information

Sponsor

Philips Clinical & Medical Affairs Global

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Philips Clinical & Medical Affairs Global on 2026-02-27.