Study Results
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View full resultsBasic Information
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COMPLETED
NA
106 participants
INTERVENTIONAL
2020-10-05
2020-11-02
Brief Summary
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The purpose of the study is to validate the clinical performance of the Masimo noninvasive blood pressure device compared to reference auscultatory measurements.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Test subjects
All subjects enrolled had blood pressure measurements taken using the noninvasive blood pressure device.
Masimo Noninvasive Blood Pressure Device
Non-invasive blood pressure device
Interventions
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Masimo Noninvasive Blood Pressure Device
Non-invasive blood pressure device
Eligibility Criteria
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Inclusion Criteria
* Site 1; Stage 1 only: Subjects with a history of hypertension (\> 140/85 mmHg) or hypotension (\< 100/60 mmHg) within the last 3 months. Stage 2 only: No criterion for blood pressure
* Site 2; Stage 1 and 2: Subjects with systolic blood pressure \< 140/90 mmHg.
* Ability to provide informed consent
Exclusion Criteria
* Subjects displaying respiratory symptoms, or with suspected respiratory illness
* Subjects whose skin is not intact, e.g. wounded, in or at the vicinity of the cuff placement site
* Subjects with removed axillary lymph nodes or mastectomies
* Subjects with peripheral artery disease
* Pregnant women (patient reported)
* Subjects deemed not suitable for the study at the discretion of the investigator
18 Years
ALL
Yes
Sponsors
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Masimo Corporation
INDUSTRY
Responsible Party
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Locations
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Site 2
Irvine, California, United States
Site 1
Lomita, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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TORR0004
Identifier Type: -
Identifier Source: org_study_id
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