Healthy, Hypertension, Hypotension
Conditions
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.
Interventions
DEVICEMasimo Noninvasive Blood Pressure Device
Non-invasive blood pressure device
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean and Standard Deviation of Differences Between Masimo NIBP Device and Manual Sphygmomanometer Measurements. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Subjects Masimo Noninvasive Blood Pressure Device: All enrolled subjects will have blood pressure measurements done using the Masimo NIBP device and the noninvasive blood pressure device | 106 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | screen fail | 9 |
Baseline characteristics
| Characteristic | Test Subjects |
|---|---|
| Age, Customized Age <=18 years | 0 Participants |
| Age, Customized Age >65 years | 15 Participants |
| Age, Customized Age Between 18 and 65 | 88 Participants |
| Age, Customized Age Unknown/Not reported | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity (NIH/OMB) Asian | 26 Participants |
| Race/Ethnicity, Customized Race/Ethnicity (NIH/OMB) Black or African American | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants |
| Race/Ethnicity, Customized Race/Ethnicity (NIH/OMB) More than one race | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity (NIH/OMB) Other | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity (NIH/OMB) Unkown or Not Reported | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity (NIH/OMB) White | 48 Participants |
| Region of Enrollment United States | 106 participants |
| Sex/Gender, Customized Gender Female | 59 Participants |
| Sex/Gender, Customized Gender Male | 44 Participants |
| Sex/Gender, Customized Gender Unknown/Not Reported | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 106 |
| other Total, other adverse events | 0 / 106 |
| serious Total, serious adverse events | 0 / 106 |
Outcome results
Primary
Mean and Standard Deviation of Differences Between Masimo NIBP Device and Manual Sphygmomanometer Measurements.
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.
Time frame: 1 hour
Population: Subjects excluded from analysis were as follows:~* 9 Subjects were screen fails~* 8 Subjects excluded during data analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Subjects | Mean and Standard Deviation of Differences Between Masimo NIBP Device and Manual Sphygmomanometer Measurements. | Systolic Blood Pressure | -1.23 mmHg | Standard Deviation 7.32 |
| Test Subjects | Mean and Standard Deviation of Differences Between Masimo NIBP Device and Manual Sphygmomanometer Measurements. | Diastolic Blood Pressure | -2.67 mmHg | Standard Deviation 7.13 |