Expired Study
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Tampa, Florida 33614


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

CS 348


NCT ID:

NCT00603486


Secondary ID:


Study Acronym:


Brief Title:

SuperSTAT Noninvasive Blood Pressure Monitor Evaluation


Official Title:

SuperSTAT Noninvasive Blood Pressure Monitor Evaluation


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

3 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

GE Healthcare


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case-Only, Time Perspective:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

20


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Laura Haubner, MD
Principal Investigator
University of South Florida

Study Dates

Start Date:November 2007
Completion Date:July 2008
Completion Type:Anticipated
Primary Completion Date:May 2008
Primary Completion Type:Actual
Verification Date:July 2008
Last Changed Date:July 22, 2008
First Received Date:January 7, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Evaluation of one of the GE DINAMAP NIBP Monitor algorithms, SuperSTAT NIBP, in neonatal and/or infant subjects.
Time Frame:1 year
Safety Issues:False

Study Interventions

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

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:GE Healthcare

Samples and Retentions

Study Population: Neonates in the NICU and newborn areas and/or infants.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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