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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-cardiac Surgical; Intensive Care Unit (ICU)
• Intervention / Treatment: Device: Philips Advanced Monitoring Cuff (i.e. AMC)

Detailed Description

Primary Objective:

• To evaluate equivalence of BP measurements (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP], and Mean Arterial Pressure [MAP]) derived from the Philips AMC to the radial arterial line as ground truth.

Secondary Objectives:

• To evaluate equivalence of Pulse Rate (PR) obtained by the Philips AMC to the radial arterial line as the ground truth.
• To evaluate equivalence of Pulse Pressure Variation (PPV) obtained by the Philips AMC to calculated PPV obtained using the radial arterial line waveform pulse pressures as the ground truth.
• To evaluate equivalence of Stroke Volume Variation (SVV) obtained by the Philips AMC to calculated SVV (e.g. from a predicate device that uses the radial arterial line waveform) as the ground truth.
• To evaluate superiority of blood pressure measurements obtained by the Philips AMC to the oscillometric non-invasive blood pressure (NIBP) cuff, with the radial arterial line as the reference.
• To evaluate trending agreement of BP and fluid responsiveness measurements.
• To assess time to apply the Philips AMC relative to the radial arterial line.
• To assess time from set-up start to first measurement completion between the Philips AMC and radial arterial line.
• To collect and report safety data from the Philips AMC.
• To collect and report system user experience and satisfaction scores from Philips AMC users.
• To create a research dataset with the collected data to use for future hemodynamic algorithm development and validation.

Hypothesis: Blood pressure measurements derived from the Philips AMC are equivalent to the radial arterial line and superior to the oscillometric non-invasive blood pressure (NIBP) cuff.

• Study Type: Observational
• Enrollment (Estimated): 205

Contacts and Locations

• Study Contact: Name: Lea Egger; Phone Number: +49 1722314318; Email: lea.egger@philips.com

Study Locations

• Germany
  • Bavaria
    • München, Bavaria, Germany, 81377
      • Recruiting
      • LMU Klinikum , Campus Großhadern
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Health System
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest Baptist Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); Investigational, non-invasive upper arm cuff

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: BP, FR, DBP, MAP, SBP, A-line
• Other Study ID Numbers: BP FR_ AMC vs A-line and NIBP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No