SuperSTAT Noninvasive Blood Pressure Monitor Evaluation

Non-Invasive Blood Pressure Clinical Trial

Official title:

SuperSTAT Noninvasive Blood Pressure Monitor Evaluation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00603486
• Other study ID #: CS 348
• Status: Active, not recruiting
• Phase: N/A
• First received: January 7, 2008
• Last updated: July 22, 2008
• Start date: November 2007
• Est. completion date: July 2008

Study information

• Verified date: July 2008
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The accuracy and/or performance of the GE DINAMAP noninvasive blood pressure (NIBP) monitors may be improved with modifications in software and/or hardware monitoring techniques and/or accessories. When changes are being made to the GE Monitor, testing can be done to evaluate performance of the investigational devices during and/or after product development.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: July 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 3 Years

Eligibility

Inclusion criteria

• Signed informed consent

• Ability to single or dual monitor NIBP, ECG, and/or SpO2, whether or not already being monitored for any or all of these parameters.

Exclusion Criteria

• Any subject deemed too unstable, at the clinician's discretion, to participate in the study

• Any subject with a cardiac anomaly that would cause a disparity between aortic pressures and the periphery.

• Any subject who cannot tolerate, in the opinion of the clinician, multiple blood pressure measurements

• Known disease state or medical condition that A) compromises circulation to the extremity (ies), B) compromises musculo-skeletal integrity, or C) otherwise contraindicates use of a NIBP cuff and/or SpO2 sensor on an extremity or ECG patches on skin

• Excessive movement or excitability causing false values or no determinations (SP10 accuracy study only)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Non-Invasive Blood Pressure

Intervention

Device:
• GE DINAMAP with SuperSTAT algorithm monitor
Apply cuff on a limb, cuff is inflated and deflated, monitor will displays non-invasive blood pressure values (systolic, diastolic, MAP, and pulse rate)

Locations

Country	Name	City	State
United States	GE Healthcare	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of one of the GE DINAMAP NIBP Monitor algorithms, SuperSTAT NIBP, in neonatal and/or infant subjects.		1 year	No