HIPULSE (Blood Pressure) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to assess how accurately a medical device under test that can measure blood pressure and changes to blood pressure during surgery non-invasively. We want to compare its performance and accuracy to that of an arterial line, which is an invasive procedure.

What is the Condition Being Studied?

Arterial Blood Pressure Monitoring in the Operating Room or Intensive Care

Who Can Participate in the Study?

Adults ages 18+ who:

  • Have an upcoming surgery or current or planned stay in the ICU
  • Are not having an emergency surgery
  • Do not have severe aortic or mitral valve dysfunction

For more information, contact the study team at emmalee.metzler@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, we will apply the study device (cuff) to your arm during your surgery or ICU stay, whichever might be applicable. We will collect blood pressure information during this time. We will then remove the device. We will check your arm for any redness, irritation, or issues.

Study Details

Full Title
The HIgh-fidelity hydraulic couPling Upper-arm cuff assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial (Blood Pressure)
Principal Investigator
Timothy E. Miller, MB ChB
Anesthesiologist
Protocol Number
IRB: PRO00118179
NCT: NCT06895590
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
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