Blood Pressure
Conditions
Keywords
Blood pressure (low, normal, high)
Brief summary
The purpose of this study is to establish the performance of a blood pressure cuff. The hypothesis is that the blood pressure reading from the cuff will provide similar blood pressure as a radial artery.
Detailed description
Blood pressure reading from the cuff will provide similar blood pressure as a radial artery.
Interventions
DEVICEBP monitoring using two methods
BP readings from participant using invasive radial arterial line, Non-invasive cuff with SuperSTAT NIBP algorithm, and Non-invasive cuff with Classic NIBP algorithm.
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Ability to provide written informed consent or have a legally authorized representative provide written informed consent * Any volunteer subjects ≥ 18 years of age * Subject must have the presence of normal sinus rhythm on ECG * Subject will return for follow-up visit from 5 days to 8 days after study procedure
Exclusion criteria
* Any subject who is unable to provide written informed consent * Any subject with the presence of peripheral vascular disease in either arm * Any subject that demonstrates an initial NIBP screening for a blood pressure distribution range that has already been filled. * Any subject who cannot tolerate 21 repeated BP measurements * Any subjects with clotting or bleeding disorders * Any subjects taking medications that are considered anticoagulants or blood thinners (For example, Clopidogrel, Warfarin, Dipyridamole, Aspirin, and Enoxaparin) * Any subject who is unable to have arterial line placed in the radial artery * Any subject that cannot tolerate 4 fast flushes for the frequency response * Any female subjects pregnant or lactating * Any subject that has previously participated in this study * Any subjects that cannot return 5 to 8 days post study procedure for a follow-up visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance Comparison: NIBP Forearm Cuff Using SuperStat Algorithm vs. Invasive Radial Blood Pressure Reading | Approximately 2 hours | NIBP Forearm cuff systolic and diastolic values using SuperStat algorithm compared to invasive radial blood pressure systolic and diastolic values (both obtained simultaneously). |
| Performance Comparison: NIBP Forearm Cuff Using Classic Algorithm vs. Invasive Radial Blood Pressure Reading | Approximately 2 hours | NIBP Forearm cuff systolic and diastolic values using Classic algorithm difference compared to invasive radial blood pressure readings (both readings obtained simultaneously). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Blood Pressure Monitoring Blood Pressure Monitoring using two methods: invasive radial line insertion and non-invasive blood pressure cuff | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Blood Pressure Monitoring |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Age, Continuous | 41.3 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 34 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
Performance Comparison: NIBP Forearm Cuff Using Classic Algorithm vs. Invasive Radial Blood Pressure Reading
NIBP Forearm cuff systolic and diastolic values using Classic algorithm difference compared to invasive radial blood pressure readings (both readings obtained simultaneously).
Time frame: Approximately 2 hours
Population: Blood Pressure (BP) monitoring using invasive arterial insertion as a standard reference, and an investigational, non-invasive blood pressure (NIBP) monitoring cuff. Data obtained from the cuff used the Classic NIBP algorithm for output.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blood Pressure Monitoring | Performance Comparison: NIBP Forearm Cuff Using Classic Algorithm vs. Invasive Radial Blood Pressure Reading | Systolic value | 0.68 mmHg | Standard Deviation 7.1 |
| Blood Pressure Monitoring | Performance Comparison: NIBP Forearm Cuff Using Classic Algorithm vs. Invasive Radial Blood Pressure Reading | Diastolic value | 0.42 mmHg | Standard Deviation 3.64 |
Primary
Performance Comparison: NIBP Forearm Cuff Using SuperStat Algorithm vs. Invasive Radial Blood Pressure Reading
NIBP Forearm cuff systolic and diastolic values using SuperStat algorithm compared to invasive radial blood pressure systolic and diastolic values (both obtained simultaneously).
Time frame: Approximately 2 hours
Population: Blood Pressure (BP) monitoring using invasive arterial insertion as a standard reference, and an investigational, non-invasive blood pressure (NIBP) monitoring cuff. Data obtained from the cuff used the SuperStat algorithm for output.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blood Pressure Monitoring | Performance Comparison: NIBP Forearm Cuff Using SuperStat Algorithm vs. Invasive Radial Blood Pressure Reading | Systolic value | -0.94 mmHg | Standard Deviation 6 |
| Blood Pressure Monitoring | Performance Comparison: NIBP Forearm Cuff Using SuperStat Algorithm vs. Invasive Radial Blood Pressure Reading | Diastolic value | 1.39 mmHg | Standard Deviation 3.69 |