Validation of Noninvasive Blood Pressure Device

Masimo

Status: Completed

Conditions: Hypotension; Hypertension; Healthy

Treatments: Device: Masimo Noninvasive Blood Pressure Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT04676152

TORR0004

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 1 patient group

Test subjects

Experimental group

Description:

All subjects enrolled had blood pressure measurements taken using the noninvasive blood pressure device.

Treatment:

Device: Masimo Noninvasive Blood Pressure Device