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OpenTrials
Completed

NCT Number: NCT04676152

Validation of Noninvasive Blood Pressure Device

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.

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Key information

Conditions

Healthy Cardiovascular Diseases Hypertension Hypotension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Site 2, Irvine, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Masimo Noninvasive Blood Pressure Device

Device

Non-invasive blood pressure device

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 19, 2020
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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