Validation of Noninvasive Blood Pressure Device

Masimo Corporation106 enrolled

Overview

This is a prospective, nonrandomized multi-center study for the investigation of noninvasive sphygmomanometers. The purpose of the study is to validate the clinical performance of the Masimo noninvasive blood pressure device compared to reference auscultatory measurements.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

106

Conditions

Healthy Hypertension Hypotension

Interventions

Masimo Noninvasive Blood Pressure DeviceDEVICE

Non-invasive blood pressure device

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 years and older * 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: * Febrile subjects * 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

Locations (2)

Site 2

Irvine, California, United States

Site 1

Lomita, California, United States

Outcomes

Primary Outcomes

Mean and Standard Deviation of Differences Between Masimo NIBP Device and Manual Sphygmomanometer Measurements.

Performance will be determined by calculating the mean and standard deviation of the differences between the systolic and diastolic blood pressure measurements obtained from Masimo NIBP device and manual sphygmomanometer.

Time frame: 1 hour

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.