Back to resultsValidation of Noninvasive Blood Pressure Device
Primary Purpose
Healthy, Hypertension, Hypotension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Masimo Noninvasive Blood Pressure Device
Sponsored by
About this trial
This is an interventional other trial for Healthy
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
Sites / Locations
- Site 2
- Site 1
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Test subjects
Arm Description
All subjects enrolled had blood pressure measurements taken using the noninvasive blood pressure device.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04676152
Brief Title
Validation of Noninvasive Blood Pressure Device
Official Title
Validation of Noninvasive Blood Pressure Device
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
November 2, 2020 (Actual)
Study Completion Date
November 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masimo Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Hypertension, Hypotension
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test subjects
Arm Type
Experimental
Arm Description
All subjects enrolled had blood pressure measurements taken using the noninvasive blood pressure device.
Intervention Type
Device
Intervention Name(s)
Masimo Noninvasive Blood Pressure Device
Intervention Description
Non-invasive blood pressure device
Primary Outcome Measure Information:
Title
Mean and Standard Deviation of Differences Between Masimo NIBP Device and Manual Sphygmomanometer Measurements.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Site 2
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Site 1
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
12. IPD Sharing Statement
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Validation of Noninvasive Blood Pressure Device
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