Purpose of this Study
We are doing this study to assess how accurately a medical device called the Philips Advanced Monitoring Cuff can measure blood pressure and changes to blood pressure during surgery. We want to compare its performance and accuracy to that of an arterial line, which is an invasive procedure.
Who Can Participate?
Eligibility
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
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
The HIgh-fidelity hydraulic couPling Upper-arm cuff assessment of Limits, Safety,
and Effectiveness (HIPULSE) Trial (Blood Pressure)
and Effectiveness (HIPULSE) Trial (Blood Pressure)
Principal Investigator
Timothy
Miller
Protocol Number
PRO00118179
NCT ID
NCT06895590
Phase
II
Enrollment Status
Open to Enrollment