High-fidelity upper-arm cuff for measuring cardiac output (HIPULSE)
Official title: The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial (Cardiac Output Study)
Run by Philips Clinical & Medical Affairs Global · NCT06895603 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | Philips Clinical & Medical Affairs Global Industry-sponsored |
| Locations | 2 sites (Charlottesville, Virginia and 1 other locations) |
| Status | Recruiting |
| Started | October 28, 2025 |
| Main results expected | February 2026 |
| Study ends | June 2026 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT06895603 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: lea.egger@philips.com
- Phone: +49 172 2314 318
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
ICU Delirium Playbook: Training for ICU Nurses
This program tests a multimedia training resource to help ICU nurses better screen for and manage delirium in critically ill patients.
-
Early Intervention After Sepsis-ICU to Reduce PTSD
This study tests whether an early psychiatric interview after discharge from the ICU for sepsis can help reduce PTSD and related symptoms.
-
Indirect calorimetry-guided nutrition in critically ill adults
This study tests whether using indirect calorimetry to guide how much energy ICU patients receive improves quality of life three months after ICU stay.
-
Low-flow ECCO2R for ICU patients with respiratory failure: safety and outcomes
This review looks back at adults in the ICU who received low-flow ECCO2R to see if the treatment was safe and helped people with respiratory failure, including ARDS and severe asthma.
-
Using the Peripheral Perfusion Index to predict extubation success
This will test whether the Peripheral Perfusion Index (PPI) can help predict if adult ICU patients will be successfully extubated after a spontaneous breathing trial.
-
Connected and disconnected consciousness after long ICU stays
This project will see how often adult ICU survivors who were in a coma report near-death or out-of-body experiences and what factors are linked to those episodes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.