Comparison of Non-Invasive Blood Pressure Methods

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-04

Study Completion Date

2020-03-03

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.

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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).

Conditions

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Blood Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

The Vital Detect blood pressure monitor

Intervention Type DEVICE

The end goal is to provide Non-invasive Blood Pressure (NIBP) accuracy data to support validation of the Vital Detect blood pressure monitor.

Interventions

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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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes