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| Name | Class |
|---|---|
| Clinimark, LLC | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISO 81060-2:2018. | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Vital Detect blood pressure monitor | Device | The end goal is to provide Non-invasive Blood Pressure (NIBP) accuracy data to support validation of the Vital Detect blood pressure monitor. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) \ | 1 Hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Batchelder | Clinimark Laboratory Services | Principal Investigator |
| Dena M Raley | Clinimark Laboratory Services | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinimark Laboratory Services | Louisville | Colorado | 80027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2360731 | Background | Bickler PE, Schapera A, Bainton CR. Acute radial nerve injury from use of an automatic blood pressure monitor. Anesthesiology. 1990 Jul;73(1):186-8. doi: 10.1097/00000542-199007000-00030. No abstract available. | |
| 7365605 | Background | Tollner U, Bechinger D, Pohlandt F. Radial nerve palsy in a premature infant following long-term measurement of blood pressure. J Pediatr. 1980 May;96(5):921-2. doi: 10.1016/s0022-3476(80)80582-8. No abstract available. |
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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.
The final study population consisted of 85 qualified healthy subjects ranging from 18 to 81 years of age of any racial / ethnic background.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) \ | 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 | Posted | Mean | Standard Deviation | mmHg | 1 Hour |
up to 15 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Two types of device deficiencies. First was the device would go through its measurement process as expected but did not provide a reading at end of deflation.Second involved connectivity issues between the Vital Detect and the Vital USA app.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark H Khachaturian, PhD | Vital USA Inc. | +1(561)282-6074 | mark.khachaturian@vvvital.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 17, 2019 | Feb 26, 2020 | Prot_SAP_000.pdf |
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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
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| 3585434 | Background | Celoria G, Dawson JA, Teres D. Compartment syndrome in a patient monitored with an automated blood pressure cuff. J Clin Monit. 1987 Apr;3(2):139-41. doi: 10.1007/BF00858363. |
| 3783197 | Result | Bause GS, Weintraub AC, Tanner GE. Skin avulsion during oscillometry. J Clin Monit. 1986 Oct;2(4):262-3. doi: 10.1007/BF02851174. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Local subjects, within the region of Avista Adventist Hospital Plaza in Louisville, CO USA | Count of Participants | Participants |
|
| Noninvasive Blood Pressure Measurement | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | 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. |
|
|
| 0 |
| 85 |
| 0 |
| 85 |
| 0 |
| 85 |
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