Blood Pressure
Conditions
Keywords
Blood pressure, Non-Invasive
Brief summary
The primary objective of the study is to demonstrate the accuracy in healthy adults with Vital USA Device by comparison to a non-invasive (auscultatory) reference sphygmomanometer. The procedure, data collection methods and data analysis that are outlined in the protocol follow the standard: International Standards Organization (ISO) 81060-2:2018 Non-invasive Sphygmomanometers - Part 2: Clinical validation of automated measurement type.
Detailed description
This study will include up to 100 adults ≥ 18 years of age. The final subject database will contain no fewer than 85 subjects with a minimum of 255 paired observations. At least 90% of the subjects will contribute 3 paired observations, if necessary the balance of the data will be added from additional subjects. An interim analysis will be conducted at the end of Part 1 data collection and will consist of simple statistics that will compare the test device tot he reference cuff non-invasive (auscultatory) reference sphygmomanometer. Part 2 data collection will be conducted after Part 1 data collection interim report is reviewed and additional data collection is approved by the client. It will test an additional 55 subjects (plus extra subjects as replacements if necessary).
Interventions
DEVICEThe Vital Detect blood pressure monitor
The end goal is to provide Non-invasive Blood Pressure (NIBP) accuracy data to support validation of the Vital Detect blood pressure monitor.
Sponsors
Clinimark, LLC
Vital USA, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The Vital Detect blood pressure monitor will be evaluated as a comparative, single center, non-randomized, study in a minimum of 30 subjects, conducted in 2 phases. The maximum number of subjects enrolled is 150 for both phases, to achieve 85 valid data sets. Each subject test is expected to take up to 1 hour
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be able to provide an informed consent or have legally authorized representative consent to participate. * Subject must be willing and able to comply with the study procedures. * Subject must be ≥ 18 * Subject or legally authorized representative must be able to read or write in English. * Subjects with a finger circumference \< 8.3 cm.in the range of 10-25 mm * At least 30% of subjects shall be male and at least 30% of subjects shall be female
Exclusion criteria
* Lack of Informed consent. * Subjects with deformities or abnormalities that may prevent proper application of the device under test. * Subject is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study. * Subjects with known heart dysrhythmias * Subjects with compromised circulation or peripheral vascular disease. * Subjects with clotting disorders or taking prescribed blood thinners. * Subjects that cannot tolerate sitting for up to 1 hour. * Subject with a blood pressure demographic that has already been filled
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor. | 1 Hour | The primary objective of this study is to provide a validation for non-invasive blood pressure measurement accuracy for the Vital Detect blood pressure monitor when compared to the Reference Sphygmomanometer. Data taken was based on dual observers (Criterion 1(C1), Criterion 2 (C2) for both Systolic and Diastolic determinations. Since the same arm sequential method was used, data for a given subject were averaged to create the reference blood pressure determination against the acceptance criteria. The device under test (DUT) passed or failed the determination based on the mean error and standard deviation of the determination. The acceptance criteria: Criterion 1: Mean Error Standard Deviation (Systolic / Diastolic) (Systolic / Diastolic) \</= 5.0 mmHg \</= 8.0 mmHg Criterion 2: Standard Deviation (Systolic) (Diastolic) \</= 5.33 mmHg \</= 6.09 mmHg |
Countries
United States
Participant flow
Recruitment details
The final study population consisted of 85 qualified healthy subjects ranging from 18 to 81 years of age of any racial / ethnic background.
Pre-assignment details
The subjects understood the study and provided consent for participation by signing the Independent Review Board (IRB) approved Informed Consent Form prior to start of the test. The subjects were informed about the clinical investigation within his/her ability to understand following the established informed consent process.
Participants by arm
| Arm | Count |
|---|---|
| ISO 81060-2:2018. The intended purpose of the test is to evaluate the Vital Detect blood pressure monitor to ISO 81060-2:2018. The intended use for these products are manual and automatic Non-Invasive Blood Pressure monitoring on adults age 18 and older.
The Vital Detect blood pressure monitor: The end goal is to provide Non-invasive Blood Pressure (NIBP) accuracy data to support validation of the Vital Detect blood pressure monitor. | 85 |
| Total | 85 |
Baseline characteristics
| Characteristic | ISO 81060-2:2018. | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 85 Participants | — |
| Noninvasive Blood Pressure Measurement | 85 participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 85 Participants | — |
| Sex: Female, Male Female | 51 Participants | — |
| Sex: Female, Male Male | 34 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 85 |
| other Total, other adverse events | 0 / 85 |
| serious Total, serious adverse events | 0 / 85 |
Outcome results
Primary
Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor.
The primary objective of this study is to provide a validation for non-invasive blood pressure measurement accuracy for the Vital Detect blood pressure monitor when compared to the Reference Sphygmomanometer. Data taken was based on dual observers (Criterion 1(C1), Criterion 2 (C2) for both Systolic and Diastolic determinations. Since the same arm sequential method was used, data for a given subject were averaged to create the reference blood pressure determination against the acceptance criteria. The device under test (DUT) passed or failed the determination based on the mean error and standard deviation of the determination. The acceptance criteria: Criterion 1: Mean Error Standard Deviation (Systolic / Diastolic) (Systolic / Diastolic) \</= 5.0 mmHg \</= 8.0 mmHg Criterion 2: Standard Deviation (Systolic) (Diastolic) \</= 5.33 mmHg \</= 6.09 mmHg
Time frame: 1 Hour
Population: The final study population consisted of 85 qualified healthy subjects ranging from 18 to 81 years of age of any racial / ethnic background. The subjects were healthy showing no evidence
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ISO 81060-2:2018. | Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor. | Systolic Pressure C1 | 4.40 mmHg | Standard Deviation 10.97 |
| ISO 81060-2:2018. | Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor. | Diastolic Pressure C1 | 3.26 mmHg | Standard Deviation 7.21 |
| ISO 81060-2:2018. | Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor. | Diastolic Pressure C2 | 3.26 mmHg | Standard Deviation 6.72 |
| ISO 81060-2:2018. | Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor. | Systolic Pressure C2 | 4.40 mmHg | Standard Deviation 9.24 |