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

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Device: BP monitoring using two methods

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Louisville, Colorado, United States, 80027
      • Clinimark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Blood Pressure monitoring; 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.	Device: BP monitoring using two methods; BP readings from participant using invasive radial arterial line, Non-invasive cuff with SuperSTAT NIBP algorithm, and Non-invasive cuff with Classic NIBP algorithm.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Principal Investigator: David Ransom, MD, Clinimark, LLC

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: December 1, 2011
• First Submitted That Met QC Criteria: December 2, 2011
• First Posted (Estimate): December 5, 2011

Study Record Updates

• Last Update Posted (Actual): May 31, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Blood pressure (low, normal, high)
• Other Study ID Numbers: 118.02-2011-GES-0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes