B40 Non-Invasive Blood Pressure Equivalency Study

NCT01546285 | Completed Results

• 1 other identifier: 118.04-2011-GES-0002
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.

Conditions

Blood Pressure

Keywords

The focus of this study is to demonstrate that DINAMAP® SuperSTATTM NIBP algorithm has been implemented correctly without performance losses to the B40 monitor

Outcome Measures

Primary Outcomes (1)

• Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements

  The primary endpoints are the difference in systolic, diastolic and mean blood pressure values between the B40 Monitor and PRO1000. The mean of the difference should be no more than 5mmHg and the standard deviation of the difference should be no more than 8mmHg per the AAMI SP-10 standard.

  End of each blood pressure reading

Study Arms (1)

Blood Pressure Reading

EXPERIMENTAL

Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings

Device: Blood Pressure Readings on B40 Patient Monitor

Interventions

Blood Pressure Readings on B40 Patient Monitor DEVICE

Simultaneous blood pressure reading on the Investigational B40 patient monitor and DINAMAP PRO1000 patient monitor

Blood Pressure Reading

Eligibility Criteria

• Age: 3 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written informed consent or have a legally authorized representative including a parent or guardian provide written informed consent
• Within the age range from older than 3 years old to 75 years old (adult and child)
• Ability to maintain proper placement of cuff and/or probe and/or sensor

You may not qualify if:

• Neonates (ages 0-29 days) and infants (30 days to 3 years old) shall be excluded
• Any subject deemed too unstable, by clinician's discretion, or for another reason deemed unacceptable for study by the clinician
• Known dysrhythmias (when applicable)
• Known disease state that compromises circulation to the extremity
• Vigorous exercise prior to participating in the study
• Excessive movement or excitability causing false values or no determinations
• Known allergy to latex when latex products will be in contact with subject
• Pregnant females

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Clinimark

Louisville, Colorado, 80027, United States

Location

Results Point of Contact

• Title: Jeffrey Conner - Global Research Manager
• Organization: GE Healthcare

Jeffrey.Conner@ge.com

414.721.2423

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2012
• First Posted: March 7, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 21, 2013
• Results First Posted: June 21, 2013

Record last verified: 2013-05

Locations

US (1)