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

Not yet recruiting

• Conditions: ICU; Surgical Patients

• Registration Number: NCT06895603
• Lead Sponsor: Philips Clinical & Medical Affairs Global

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-19
• Study First Posted: 2025-03-26
• Last Update Posted: 2025-03-26
• Study Start: 2025-06
• Primary Completion: 2026-02
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Endpoints	Approximately 8 months for accrual and follow-up	The comparison of cardiac output between the Philips AMC and PAC