HIPULSE Trial Comparing Philips Advanced Monitoring Cuff and Pulmonary Artery Catheter for Cardiac Output in ICU and Surgical Patients

What this Trial Is About

Researchers are comparing cardiac output, fluid responsiveness, and related measurements between a new non-invasive device, the Philips Advanced Monitoring Cuff AMC, and the standard pulmonary artery catheter PAC known as the Swan-Ganz catheter. This observational study involves adult patients in intensive care units or surgical settings who require monitoring with a PAC. The study aims to assess the accuracy and safety of the Philips AMC device for measuring heart function. Participants will include up to 75 ICU patients monitored with a PAC, without randomization. The Philips AMC device is a disposable upper arm cuff that uses hydraulic coupling to capture tissue pressure waveforms non-invasively. The study includes a roll-in phase with about 20 patients and a pivotal phase with about 55 patients, conducted across multiple sites over approximately eight months. During the study, researchers will monitor participants using both the Philips AMC and the PAC to compare measurements. Data will be collected throughout the ICU or surgical monitoring period. The main outcome measured is the primary endpoints related to cardiac output and fluid responsiveness during the eight-month accrual and follow-up period. Participants will undergo assessments as part of their regular monitoring, with no additional invasive procedures beyond those clinically indicated.

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