High-fidelity upper-arm cuff for measuring cardiac output (HIPULSE)

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

This project will test whether a new Philips upper-arm monitoring cuff can measure cardiac output and fluid responsiveness as accurately as a Swan-Ganz (pulmonary artery) catheter in ICU or surgical patients who need invasive monitoring.

Quick facts

• Study type: Observational
• Enrollment: 75 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Philips Clinical & Medical Affairs Global (Industry-sponsored)
• Locations: 2 sites (Charlottesville, Virginia and 1 other locations)
• Trial ID: NCT06895603 on ClinicalTrials.gov

What this trial studies

This is an observational comparison of the Philips Advanced Monitoring Cuff (AMC) versus the pulmonary artery (Swan-Ganz) catheter for cardiac output, fluid responsiveness, and related hemodynamic measurements. Adult ICU and perioperative patients who have clinical indications for a PAC and a radial arterial line will have simultaneous measurements recorded from both devices. The protocol excludes emergency surgery, certain patient positions (arms tucked or lateral), incompatible arm anatomy, pregnancy, intra-aortic balloon pump use, and extremes of arm circumference or BMI. Data will be collected at participating academic centers (UVA Health and Universitätsklinikum Hamburg Eppendorf) to quantify agreement and limits of agreement between the devices.

Who should consider this trial

Good fit: Adults (≥18) in ICU or perioperative settings who require a Swan-Ganz catheter and radial arterial line, have arm circumference between 19–43 cm and BMI ≤45, and can provide informed consent are ideal candidates.

Not a fit: Patients undergoing emergency surgery, with both arms tucked or lateral positioning, incompatible arm anatomy, pregnancy, intra-aortic balloon pump support, or enrollment in conflicting investigational studies may not benefit from this device comparison.

Why it matters

Potential benefit: If successful, the upper-arm cuff could offer a less invasive, easier way to monitor cardiac output and fluid responsiveness at the bedside.

How similar studies have performed: Other noninvasive and less-invasive cardiac output monitors have shown mixed accuracy versus PAC, so an upper-arm hydraulic coupling approach is relatively novel and requires direct comparison to established PAC measurements.

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

Where this trial is running

Charlottesville, Virginia and 1 other locations

• UVA Health — Charlottesville, Virginia, United States (Recruiting)
• Universitätsklinikum Hamburg Eppendorf — Hamburg, Free and Hanseatic City of Hamburg, Germany (Recruiting)

Study contacts

• Study coordinator: Lea Egger

Conditions ICU; Pulmonary Artery Catheter; Swan-Ganz Catheter