Validation of Noninvasive Blood Pressure Device

Not Applicable

Completed

• Conditions: Healthy; Hypertension; Hypotension

• Registration Number: NCT04676152
• Lead Sponsor: Masimo Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-05
• Primary Completion: 2020-11-02
• Study Completion: 2020-11-02
• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-19
• Disposition First Submitted: 2021-10-14
• Results First Submitted: 2023-06-29
• Results First Submitted QC: 2023-08-18
• Results First Posted: 2023-09-13
• Disposition First Posted: 2023-09-13
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (2)

Site 2; 🇺🇸 Irvine, California, United States

Site 1; 🇺🇸 Lomita, California, United States