Recruiting

Blood Pressure Comparison

Sponsor:

Philips Clinical & Medical Affairs Global

Code:

NCT06895590

Conditions

Non-cardiac Surgical

Intensive Care Unit (ICU)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Philips Advanced Monitoring Cuff (i.e. AMC)

Study Details

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)

Study ID

NCT06895590

Start date

Oct 2, 2025

Status verified date

Feb, 2026

Completion date

Feb, 2026

Anticipated

Primary completion date

Feb, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

205 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Philips Advanced Monitoring Cuff (i.e. AMC)

Investigational, non-invasive upper arm cuff

Primary outcome measure

  • Primary Endpoints [ Time Frame: Approximately 8 months accrual and follow-up evaluation period. ]

Central Contacts and Locations

Central contacts

Lea Egger

+49 1722314318lea.egger@philips.com

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Duke University Health System

Recruiting

Durham, North Carolina, United States, 27710

Wake Forest Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

More Information

Sponsor

Philips Clinical & Medical Affairs Global

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • BP, FR, DBP, MAP, SBP, A-line

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Philips Clinical & Medical Affairs Global on 2026-02-27.