Validation of Noninvasive Blood Pressure Device

January 3, 2024 updated by: Masimo Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92618
        • Site 2
      • Lomita, California, United States, 90717
        • Site 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test subjects
All subjects enrolled had blood pressure measurements taken using the noninvasive blood pressure device.
Device: Masimo Noninvasive Blood Pressure Device
Non-invasive blood pressure device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masimo Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2020

Primary Completion (Actual)

November 2, 2020

Study Completion (Actual)

November 2, 2020

Study Registration Dates

First Submitted

November 5, 2020

First Submitted That Met QC Criteria

December 15, 2020

First Posted (Actual)

December 19, 2020

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TORR0004

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Masimo Noninvasive Blood Pressure Device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe