Non-Invasive Blood Pressure Accuracy Study for Adult Subjects

NCT07628296 | Recruiting

• 1 other identifier: SA-000259
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to collect NIBP and invasive aortic pressure data from the clinical setting.

Conditions

Blood Pressure; Blood Pressure Measurement

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure

  Collection of non-invasive blood pressure measurements data from subjects in clinical setting.

  Up to 2 hours after time of enrollment

Other Outcomes (1)

• Incidence of Safety Events

  6 months

Study Arms (3)

Small Adult vs Adult Cuff (Upper Arm, Overlap Range 23-25 cm)

EXPERIMENTAL

Subjects with an upper-arm circumference within 23-25 cm, where both Small Adult (SA) and Adult (A) cuffs are suitable, are randomized in a 1:1 ratio to receive blood pressure measurements using either: * Small Adult cuff, or * Adult cuff Subjects with upper-arm circumferences in non-overlapping SA-only ranges are assigned the Small Adult cuff without randomization and are not included in this arm.

Device: NIBP Measurement

Adult vs Large Adult Cuff (Upper Arm, Overlap Range 31-33 cm)

EXPERIMENTAL

Subjects with an upper-arm circumference within 31-33 cm, where both Adult (A) and Large Adult (LA) cuffs are suitable, are randomized in a 1:1 ratio to receive blood pressure measurements using either: Adult cuff, or Large Adult cuff Subjects with measurements in non-overlapping A-only or LA-only ranges are assigned the appropriate cuff without randomization and are not included in this arm.

Device: NIBP Measurement

Thigh Cuff (Fallback/Non-Randomized)

EXPERIMENTAL

Subjects whose arm circumference is either: * Outside the allowable upper-arm range (17-40 cm), or * Eligible but excluded due to fulfillment of upper-arm cuff quotas will undergo thigh circumference measurement. Those with a thigh circumference within 38-50 cm will receive blood pressure measurements using a thigh cuff. Subjects outside the thigh circumference range are excluded prior to any blood pressure measurements.

Device: NIBP Measurement

Interventions

NIBP Measurement DEVICE

The collection of non-invasive blood pressure measurements using NIBP Standard Parameter Module with SuperSTAT algorithm with simultaneous invasive blood pressure waveform recordings per discretion of the sponsor upon combining the data from other clinical studies to comply with ISO 81060-2:2018 +AMD2:2024.

Adult vs Large Adult Cuff (Upper Arm, Overlap Range 31-33 cm); Small Adult vs Adult Cuff (Upper Arm, Overlap Range 23-25 cm); Thigh Cuff (Fallback/Non-Randomized)

Eligibility Criteria

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

You may qualify if:

• Age requirement: 18 and over.
• Have an upper limb (right OR left side) that fits the cuff size of the device (circumference ranging 17 cm to 40 cm) OR have a thigh (right OR left side) that fits a cuff size of the device (circumference ranging 38 to 50 cm).
• Have an arterial line as a standard of care, which measures blood pressure at the aortic root.
• Able to provide written informed consent.
• Expected to remain in the unit for the duration of the study procedure.

You may not qualify if:

• Have previously participated in this study (no subject may participate more than once).
• Pregnant and lactating women per site standard of care.
• Subjects with peripheral arterial diseases (causing left/right arm difference)
• Hemodynamically unstable subjects at the discretion of the investigator.
• Exhibited injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the Investigator, may prevent proper cuff application or functioning.
• Are suffering from infection(s) or immunocompromised patients that require isolation.
• PI or designee decision due to subject health conditions

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Tampere Heart Hospital

Tampere, 33521, Finland

RECRUITING

Related Publications (2)

• Meidert AS, Saugel B. Techniques for Non-Invasive Monitoring of Arterial Blood Pressure. Front Med (Lausanne). 2018 Jan 8;4:231. doi: 10.3389/fmed.2017.00231. eCollection 2017.

  PMID: 29359130 BACKGROUND

• Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2018 Oct 23;138(17):e426-e483. doi: 10.1161/CIR.0000000000000597. No abstract available.

  PMID: 30354655 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 5, 2026
• Study Start: May 29, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)