An interventional study of The Vital Detect blood pressure monitor in Blood Pressure, sponsored by Vital USA, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-13.
Sponsored by Vital USA, Inc. · Not applicable, Interventional, and Supportive care
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.
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).
Vital USA, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: 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.
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
The final study population consisted of 85 qualified healthy subjects ranging from 18 to 81 years of age of any racial / ethnic background.
| Milestone | ISO 81060-2:2018. |
|---|---|
| Started | 85 |
| Completed | 85 |
| Not completed | 0 |
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
| mmHg | ISO 81060-2:2018. |
|---|---|
| Systolic Pressure C1 | 4.40 ± 10.97 |
| Systolic Pressure C2 | 4.40 ± 9.24 |
| Diastolic Pressure C1 | 3.26 ± 7.21 |
| Diastolic Pressure C2 | 3.26 ± 6.72 |
Collected over up to 15 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ISO 81060-2:2018. | 0/85 (0%) | 0/85 (0%) | 0/85 (0%) |
96 six subjects were screened for this study. One subject was not enrolled, and 10 subjects were withdrawn. The final study population consisted of 85 qualified healthy subjects ranging from 18 to 81 years of age of any racial / ethnic background.
| Age, Categorical(Participants) | ISO 81060-2:2018. |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 85 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | ISO 81060-2:2018. |
|---|---|
| Female | 51 |
| Male | 34 |
| Race and Ethnicity Not Collected(Participants) | ISO 81060-2:2018. |
|---|
| Region of Enrollment(Participants) | ISO 81060-2:2018. |
|---|---|
| United States | 85 |
| Noninvasive Blood Pressure Measurement(participants) | ISO 81060-2:2018. |
|---|---|
| Number | 85 |
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Vital USA, Inc.