RecruitingNCT06895590

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

Sponsor

Philips Clinical & Medical Affairs Global

Enrollment

205 participants

Start Date

Oct 2, 2025

Study Type

OBSERVATIONAL

Conditions

Intensive Care Unit ICU Non-cardiac Surgical

Summary

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

Min Age: 18 Years

Inclusion Criteria18

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 Criteria13

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