RecruitingNot ApplicableNCT07628296

Non-Invasive Blood Pressure Accuracy Study for Adult Subjects

Sponsor

GE Healthcare

Enrollment

15 participants

Start Date

May 29, 2026

Study Type

INTERVENTIONAL

Conditions

blood pressure measurement Blood Pressure

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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.

Exclusion Criteria7

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

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Interventions

DEVICENIBP Measurement

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.