NCT06895603 The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial (Cardiac Output Study)
| NCT ID | NCT06895603 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Philips Clinical & Medical Affairs Global |
| Condition | ICU |
| Study Type | OBSERVATIONAL |
| Enrollment | 75 participants |
| Start Date | 2025-10-28 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 75 participants in total. It began in 2025-10-28 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06895603 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ICU. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06895603 currently recruiting?
Yes, NCT06895603 is actively recruiting participants. Contact the research team at lea.egger@philips.com for enrollment information.
Where is the NCT06895603 trial being conducted?
This trial is being conducted at Charlottesville, United States, Hamburg, Germany.
Who is sponsoring the NCT06895603 clinical trial?
NCT06895603 is sponsored by Philips Clinical & Medical Affairs Global. The trial plans to enroll 75 participants.