Accuracy Study of a Non-Invasive Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure

General Electric (GE)

Status: Completed

Conditions: Blood Pressure

Treatments: Device: BP monitoring using two methods

Study type: Interventional

Funder types: Industry

Identifiers

NCT01485120

118.02-2011-GES-0007

Details and patient eligibility

About

The purpose of this study is to establish the performance of a blood pressure cuff. The hypothesis is that the blood pressure reading from the cuff will provide similar blood pressure as a radial artery.

Full description

Blood pressure reading from the cuff will provide similar blood pressure as a radial artery.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ability to provide written informed consent or have a legally authorized representative provide written informed consent
• Any volunteer subjects ≥ 18 years of age
• Subject must have the presence of normal sinus rhythm on ECG
• Subject will return for follow-up visit from 5 days to 8 days after study procedure

Exclusion criteria

• Any subject who is unable to provide written informed consent
• Any subject with the presence of peripheral vascular disease in either arm
• Any subject that demonstrates an initial NIBP screening for a blood pressure distribution range that has already been filled.
• Any subject who cannot tolerate 21 repeated BP measurements
• Any subjects with clotting or bleeding disorders
• Any subjects taking medications that are considered anticoagulants or blood thinners (For example, Clopidogrel, Warfarin, Dipyridamole, Aspirin, and Enoxaparin)
• Any subject who is unable to have arterial line placed in the radial artery
• Any subject that cannot tolerate 4 fast flushes for the frequency response
• Any female subjects pregnant or lactating
• Any subject that has previously participated in this study
• Any subjects that cannot return 5 to 8 days post study procedure for a follow-up visit

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Blood Pressure monitoring

Other group

Description:

Blood Pressure (BP) monitoring using invasive arterial insertion as a standard reference, and an investigational, non-invasive blood pressure (NIBP) monitoring cuff. Data obtained from the cuff used the SuperSTAT NIBP algorithm and the Classic NIBP algorithm for output.

Treatment:

Device: BP monitoring using two methods