SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement (SNIPE)

General Electric (GE)

Status: Terminated

Conditions: Blood Pressure (Low, Normal, High)

Treatments: Device: Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT01482325

118.02-2011-GES-0002

Details and patient eligibility

About

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

Enrollment: 31 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Subjects requiring blood pressure monitoring

Experimental group

Description:

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

Treatment:

Device: Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor