N/A
Completed N=106
Validation of Noninvasive Blood Pressure Device
Healthy · Hypertension · Hypotension
Source: ClinicalTrials.gov NCT04676152 ↗
Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcomePrimary: Mean and Standard Deviation of Differences Between Masimo NIBP Device and Manual Sphygmomanometer Measurements. — -1.23; -2.67 mmHg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean and Standard Deviation of Differences Between Masimo NIBP Device and Manual Sphygmomanometer Measurements. |
-1.23; -2.67 | — |
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
Data sourced from ClinicalTrials.gov (NCT04676152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.