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Recruiting NCT06895603

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

— Observational ICU Pulmonary Artery Catheter (PAC) Swan-Ganz Catheter

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Philips Advanced Monitoring Cuff (AMC).
Who it may be relevant to
Registry conditions: ICU, Pulmonary Artery Catheter (PAC), Swan-Ganz Catheter. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • UVA Health — Charlottesville
Germany · 1 center
  • Universitätsklinikum Hamburg Eppendorf — Hamburg

Identifiers

NCT: NCT06895603 · HIPULSE-CO_PAC_2021_11366

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗