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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPhilips Clinical & Medical Affairs Global

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

Up to 75 ICU patients being monitored with a PAC and radial arterial line will be enrolled over approximately 8 months accrual and follow-up evaluation period

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Philips Advanced Monitoring Cuff (AMC)

    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.

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: All patients being monitored with a pulmonary artery catheter1 intervention

Trial outcomes

Primary outcomes

1

Primary Endpoints

The comparison of cardiac output between the Philips AMC and PAC

Time frame
Approximately 8 months for accrual and follow-up

Secondary outcomes

Other outcomes

Sponsors and contacts

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