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Vital USA Respiratory Rate Validation In Adults — RR  

Respiratory Complication Clinical Trial

Official title:
Final Test Report for Vital USA Respiratory Rate Validation In Adults

Clinical Trial Summary

Vital USA is dedicated to developing and applying innovative electronic medical solutions that improve patient care in multiple clinical settings. Vital USA is a manufacturer of a multi-parameter patient monitor that is intended to be used in a variety of medical settings including hospitals, medical offices and patients' homes.

Clinical Trial Description

Purpose of Clinical Investigation Respiratory Rate is an important physiological measurement in the healthcare setting. End Tidal Carbon Dioxide (EtCO2) is considered to be the highest level of safety and accuracy in Respiratory Rate monitoring by the American Society of Anesthesiology and the American Association of Respiratory Care.

The purpose of this study was to conduct a Respiratory Rate accuracy validation comparing the Vital Detect to an FDA cleared End Tidal Carbon Dioxide monitor Reference Standard (GE Datex-Ohmeda).

Respiratory Rate is an important physiological measurement in the healthcare setting. End Tidal Carbon Dioxide (EtCO2) is considered to be the highest level of safety and accuracy in Respiratory Rate monitoring by the American Society of Anesthesiology and the American Association of Respiratory Care.

The purpose of this study was to conduct a Respiratory Rate accuracy validation comparing the Vital Detect to an FDA cleared End Tidal Carbon Dioxide monitor Reference Standard (GE Datex-Ohmeda). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04292639
Study type Interventional
Source Vital USA, Inc.
Contact
Status Completed
Phase N/A
Start date December 17, 2019
Completion date December 20, 2019
View Details
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