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SuperSTAT Noninvasive Blood Pressure Monitor Evaluation

NCT ID: NCT00603486

Last Updated: 2008-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Invasive Blood Pressure

Keywords

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Non-invasive Blood Pressure (NIBP) GE Dinamap SuperSTAT

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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)

Intervention Type DEVICE

Eligibility Criteria

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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)
Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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University of South Florida

Principal Investigators

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Laura Haubner, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

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GE Healthcare

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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CS 348

Identifier Type: -

Identifier Source: org_study_id