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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-28

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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ICU Surgical Patients

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients being monitored with a pulmonary artery catheter

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.

Philips Advanced Monitoring Cuff (AMC)

Intervention Type DEVICE

The Philips AMC is a Class II (USA) and Class IIb (EU) medical device that is a non-invasive, semirigid disposable upper arm cuff with an integrated pneumatic actuator enabling hydraulic coupling of tissue pressure waveforms from the upper arm tissue.

Interventions

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Philips Advanced Monitoring Cuff (AMC)

The Philips AMC is a Class II (USA) and Class IIb (EU) medical device that is a non-invasive, semirigid disposable upper arm cuff with an integrated pneumatic actuator enabling hydraulic coupling of tissue pressure waveforms from the upper arm tissue.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No