Validation of Noninvasive Blood Pressure Device
1 other identifier
interventional
106
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Oct 2020
Shorter than P25 for not_applicable healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2020
CompletedFirst Submitted
Initial submission to the registry
November 5, 2020
CompletedFirst Posted
Study publicly available on registry
December 19, 2020
CompletedResults Posted
Study results publicly available
September 13, 2023
CompletedJanuary 8, 2024
January 1, 2024
28 days
November 5, 2020
June 29, 2023
January 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Test subjects
EXPERIMENTALAll subjects enrolled had blood pressure measurements taken using the noninvasive blood pressure device.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Site 2
Irvine, California, 92618, United States
Site 1
Lomita, California, 90717, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chelsea Frank
- Organization
- Masimo Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2020
First Posted
December 19, 2020
Study Start
October 5, 2020
Primary Completion
November 2, 2020
Study Completion
November 2, 2020
Last Updated
January 8, 2024
Results First Posted
September 13, 2023
Record last verified: 2024-01