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

Not Applicable

Completed

• Conditions: Blood Pressure
• Interventions: Device: BP monitoring using two methods

• Registration Number: NCT01485120
• Lead Sponsor: GE Healthcare

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2011-12-01
• Study First Submitted QC: 2011-12-02
• Study First Posted: 2011-12-05
• Results First Submitted: 2017-08-07
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-06
• Last Update Submitted: 2019-05-06
• Results First Posted: 2019-05-31
• Last Update Posted: 2019-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood Pressure monitoring	BP monitoring using two methods	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.

Primary Outcome Measures

Name	Time	Method
Performance Comparison: NIBP Forearm Cuff Using Classic Algorithm vs. Invasive Radial Blood Pressure Reading	Approximately 2 hours	NIBP Forearm cuff systolic and diastolic values using Classic algorithm difference compared to invasive radial blood pressure readings (both readings obtained simultaneously).
Performance Comparison: NIBP Forearm Cuff Using SuperStat Algorithm vs. Invasive Radial Blood Pressure Reading	Approximately 2 hours	NIBP Forearm cuff systolic and diastolic values using SuperStat algorithm compared to invasive radial blood pressure systolic and diastolic values (both obtained simultaneously).

Trial Locations

Locations (1)

Clinimark; 🇺🇸 Louisville, Colorado, United States