Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT04676152
NCT04676152CompletedNot Applicable

Validation of Noninvasive Blood Pressure Device

Masimo Corporation4 sites in 1 country106 target enrollmentStarted: October 5, 2020Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
106
Locations
4
Primary Endpoint
Mean and Standard Deviation of Differences Between Masimo NIBP Device and Manual Sphygmomanometer Measurements.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

Loading locations...

Similar Trials

Completed
Not Applicable
Validation of a Novel Non-invasive Continuous Blood Pressure Monitor in Children Ages 2- 17 Years-oldBlood Pressure
NCT04817137Boston Children's Hospital35
Unknown
Not Applicable
Non-Invasive Blood Pressure Monitor Accuracy in Neonatal SubjectsNon-invasive Blood Pressure
NCT02642198Mortara Instrument25
Withdrawn
Not Applicable
A Novel Non-interfering Arterial Blood Pressure Monitoring DeviceHealthyHypertensionHypotension
NCT01954446Sense A/S
Recruiting
Not Applicable
Validation of contact less Blood pressure monitoring device
CTRI/2022/06/043075Turtle Shell Technologies
Completed
Not Applicable
Noninvasive Blood Pressure Monitor Evaluation Including Performance During DysrhythmiasHealthy
NCT00443001GE Healthcare40
Validation of Noninvasive Blood Pressure... | Clinical Trial