Vital USA Respiratory Rate Validation In Adults
Condition: Respiratory Complication
Study type: Interventional

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).
    

Intervention name(s): The Vital Detect Pulse Oximeter
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): VitalDetect
Intervention model: Single Group Assignment
Intervention model description: 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.
Masking: None (Open Label)
Primary purpose: Diagnostic