Validation of Noninvasive Blood Pressure Device

Masimo Corporation2 sites in 1 country106 target enrollmentOctober 5, 2020

ConditionsHealthy Hypertension Hypotension

Overview

Phase: N/A
Intervention: Not specified
Conditions: Healthy
Sponsor: Masimo Corporation
Enrollment: 106
Locations: 2
Primary Endpoint: Mean and Standard Deviation of Differences Between Masimo NIBP Device and Manual Sphygmomanometer Measurements.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 5, 2020

End Date

November 2, 2020

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Masimo Corporation

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 1 hour

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.