Comparison of Non-Invasive Blood Pressure Methods

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Multiparameter Monitor Non-Invasive Blood Pressure Validation Study

Conditions
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Blood Pressure

Intervention / Treatment
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* Device: The Vital Detect blood pressure monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ISO 81060-2:2018.<br>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<br>* The end goal is to provide Non-invasive Blood Pressure (NIBP) accuracy data to support validation of the Vital Detect blood pressure monitor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) </= 5.0 mmHg </= 8.0 mmHg Criterion 2: Standard Deviation (Systolic) (Diastolic) </= 5.33 mmHg </= 6.09 mmHg | 1 Hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood pressure, Non-Invasive