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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485120
• Other study ID #: 118.02-2011-GES-0007
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: December 2011

Study information

• Verified date: May 2019
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

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.

Locations

Country	Name	City	State
United States	Clinimark	Louisville	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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