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

Philips

Status: Not yet enrolling

Conditions: Surgical Patients; ICU

Treatments: Device: Philips Advanced Monitoring Cuff (AMC)

Study type: Observational

Funder types: Industry

Identifiers

NCT06895603

HIPULSE-CO_PAC_2021_11366

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

75 participants in 1 patient group

All patients being monitored with a pulmonary artery catheter

Description:

Up to 75 intensive care unit patients being monitored with a pulmonary artery catheter (approximately 20 patients from at least 2 sites during the roll-in phase and approximately 55 patients during the pivotal phase) will be enrolled over an estimated 8 months accrual and follow-up evaluation period. There will be no randomization in this study.

Treatment:

Device: Philips Advanced Monitoring Cuff (AMC)