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

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 measurements of blood pressure (BP) and fluid responsiveness between the Philips AMC and invasive radial arterial line in surgical patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years and older

Indication for NIBP cuff

Indication for a radial arterial line

Subject or legal authorized representative is able to understand and speak the local language (also Spanish for US sites) to provide voluntary written informed consent prior to study procedures

Disqualifiers

Emergency surgery

Surgeries in which 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 205 non-cardiac surgical or Intensive Care Unit (ICU) patients being monitored with a 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 (i.e. AMC)

    Device

    Investigational, non-invasive upper arm cuff

Treatment groups

205 Participants
are divided into 1 treatment group
Group A: Philips AMC Cuff1 intervention

Trial outcomes

Primary outcomes

1

Primary Endpoints

The comparison of systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) between the Philips AMC and radial arterial line.

Time frame
Approximately 8 months accrual and follow-up evaluation period.

Secondary outcomes

Other outcomes

Sponsors and contacts

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