NCT04292639

Vital USA Respiratory Rate Validation In Adults

Final Test Report for Vital USA Respiratory Rate Validation In Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Vital USA, Inc. · Industry
• Sex: All
• Age: 18 Years – 52 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Respiratory Complication

Interventions

Type	Name	Description
DEVICE	The Vital Detect Pulse Oximeter	The Vital Detect is a noninvasive device designed for spot-checking physiological parameters, such as Noninvasive Blood Pressure, Oxygen Saturation, Pulse Rate, Body Temperature, and Respiratory Rate. This device is a finger-cuff technology which is applicable for use at-home or in healthcare facilities in/on individuals 18 years of age and older. It may be used by the individual themselves or an operator. The Vital Detect is not intended for continuous monitoring or for use with high frequency surgical equipment. It is non transit-operable. The Vital USA Vital Detect is composed of a sensor head mounted on a base connected to a phone or computer via Vital Detect App which is free to download.

Timeline

• Start date: 2019-12-17
• Primary completion: 2019-12-20
• Completion: 2019-12-20
• First posted: 2020-03-03
• Last updated: 2020-05-28
• Results posted: 2020-05-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study