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

NCT ID: NCT01485120

Last Updated: 2019-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2011-12-31

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.

Conditions

Blood Pressure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

BP monitoring using two methods

Intervention Type: DEVICE

BP readings from participant using invasive radial arterial line, Non-invasive cuff with SuperSTAT NIBP algorithm, and Non-invasive cuff with Classic NIBP algorithm.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Ransom, MD

Role: PRINCIPAL_INVESTIGATOR

Clinimark, LLC

Locations

Clinimark

Louisville, Colorado, United States

Countries

United States

Other Identifiers

118.02-2011-GES-0007

Identifier Type: -

Identifier Source: org_study_id