Comparison of Non-Invasive Blood Pressure Methods — NIBP  

Blood Pressure Clinical Trial

Official title: Multiparameter Monitor Non-Invasive Blood Pressure Validation Study

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Blood Pressure

• NCT number: NCT04296227
• Study type: Interventional
• Source: Vital USA, Inc.
• Status: Completed
• Phase: N/A
• Start date: February 4, 2020
• Completion date: March 3, 2020