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

NCT06895590 | Recruiting FDA Device

• 1 other identifier: BP FR_ AMC vs A-line and NIBP
• Study Type: observational
• Target: 205
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Non-cardiac Surgical; Intensive Care Unit (ICU)

Keywords

BP, FR, DBP, MAP, SBP, A-line

Outcome Measures

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.

  Approximately 8 months accrual and follow-up evaluation period.

Study Arms (1)

Philips AMC Cuff

This is a non-randomized, single arm, self-controlled observational study. The Philips AMC cuff will be tested on all enrolled participants.

Device: Philips Advanced Monitoring Cuff (i.e. AMC)

Interventions

Philips Advanced Monitoring Cuff (i.e. AMC) DEVICE

Investigational, non-invasive upper arm cuff

Philips AMC Cuff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (4)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Duke University Health System

Durham, North Carolina, 27710, United States

RECRUITING

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

LMU Klinikum , Campus Großhadern

München, Bavaria, 81377, Germany

RECRUITING

Central Study Contacts

Lea Egger

CONTACT

+49 1722314318; lea.egger@philips.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: October 2, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); DE (1)