NCT04296227

Comparison of Non-Invasive Blood Pressure Methods

Multiparameter Monitor Non-Invasive Blood Pressure Validation Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Vital USA, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Blood Pressure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-02-04
• Primary completion: 2020-03-03
• Completion: 2020-03-03
• First posted: 2020-03-05
• Last updated: 2020-05-13
• Results posted: 2020-05-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study