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NCT04676152 Clinical Trial

Validation of Noninvasive Blood Pressure Device

Healthy Clinical Trial

Official title:
Validation of Noninvasive Blood Pressure Device

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04676152
Other study ID # TORR0004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 5, 2020
Est. completion date November 2, 2020

Study information
Verified date January 2024
Source Masimo Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 106
Est. completion date November 2, 2020
Est. primary completion date November 2, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Masimo Noninvasive Blood Pressure Device
Non-invasive blood pressure device

Locations
Country Name City State
United States Site 2 Irvine California
United States Site 1 Lomita California

Sponsors (1)
Lead Sponsor Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 1 hour
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