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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
The following stratification criteria must be met across the study sites and hence targeted enrollment may be required:
* Age of every patient 18+; at least 30% \> 65 years, 30% ≤ 65 years
* At least 30% male, 30% female
* Minimum number of subjects needed to test each size cuff (per ISO81060-2:2018/AMD2:2024, based on limb circumference range):
* Adult Small (19-27 cm) = 165\*\[8/(2\*24)\] = 28
* Adult (25-34 cm) = 165\*\[9/(2\*24)\] = 31
* Adult Large Short (30-40 cm with severely conical arm) = 165\*\[10/(2\*24)\] = 35
* Adult Large (32-43 cm) = 165\*\[11/(2\*24)\] = 38
* At least 40% of the subjects within each cuff size shall have a limb circumference that lies within the upper half of the specified range of use of the cuff
* At least 40% of the subjects within each cuff size shall have a limb circumference within the lower half of the specified range of use of the cuff
* At least 10% SBP measurements ≤ 100 mmHg
* At least 10% SBP measurements ≥ 160 mmHg
* At least 10% DBP measurements ≤ 70 mmHg
* At least 10% DBP measurements ≥ 85 mmHg
Exclusion Criteria:
* 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)
* Patients treated with an intra-aortic balloon pump
* Aortic and mitral regurgitation (\> 2nd degree), if known
* Measurements taken in the lateral position
* Pressure of the arterial line system, when tested at 100 mmHg with the VeriCal device, exceeds the +/- 2 mmHg threshold
* 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
* If the average of 3 baseline NIBP lateral difference measurements for SBP is \> 15 mmHg or for DBP is \> 10 mmHg
* At the PI's discretion, subject does not qualify to participate in the study for any reasons that are not mentioned above
Primary outcome measure(s)
Primary Endpoints — Approximately 8 months accrual and follow-up evaluation period. The comparison of systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) between the Philips AMC and radial arterial line.
Trial sites (4)
Facility
City
Region
Status
Beth Israel Deaconess Medical Center
Boston
Massachusetts
Recruiting
Duke University Health System
Durham
North Carolina
Recruiting
Wake Forest Baptist Medical Center
Winston-Salem
North Carolina
Recruiting
LMU Klinikum , Campus Großhadern
München
Bavaria
Recruiting
More Philips Clinical & Medical Affairs Global trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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