SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement

NCT ID: NCT01482325

Last Updated: 2016-09-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-12-31

Brief Summary

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The primary objective of this study is to show that the noninvasive blood pressure software algorithm meets engineering requirements.

Detailed Description

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Conditions

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Blood Pressure (Low, Normal, High)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Subjects requiring blood pressure monitoring

Any subject (neonate-adult) requiring hospital or clinic blood pressure monitoring

Group Type EXPERIMENTAL

Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor

Intervention Type DEVICE

10-20 Non-Invasive Blood Pressure readings on investigational software in the DASH2500 Patient Monitor

Interventions

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Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor

10-20 Non-Invasive Blood Pressure readings on investigational software in the DASH2500 Patient Monitor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Ability to provide written informed consent or have a legally authorized representative including a parent or guardian provide written informed consent
* Ability of a minor subject ages 7 to 18 to provide written assent
* Ability to have multiple noninvasive blood pressures taken at one sitting
* Ability to apply three lead ECG, if needed for investigation
* Ability to detect the natural presence of an irregular pulse, for irregular pulse studies

Exclusion Criteria

* Any subject who cannot tolerate multiple blood pressure measurements
* Any subject who cannot undergo 3-lead ECG, if needed
* Any subject deemed unstable by the principal investigator
* Any subject for whom precautions are necessary because of communicable disease
* Any subject that has a known disease or condition compromises musculoskeletal integrity
* Any subject that has a known disease or condition that contraindicates use of an NIBP cuff and ECG patches on the skin.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St. Josephs Hospital

Milwaukee, Wisconsin, United States

Site Status

Wisconsin Heart Hospital

Wauwatosa, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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118.02-2011-GES-0002

Identifier Type: -

Identifier Source: org_study_id

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