Vital USA Respiratory Rate Validation In Adults

Respiratory Complication Clinical Trial

— RR  

Official title:

Final Test Report for Vital USA Respiratory Rate Validation In Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04292639
• Other study ID #: PR 2019-326
• Status: Completed
• Phase: N/A
• Start date: December 17, 2019
• Est. completion date: December 20, 2019

Study information

• Verified date: May 2020
• Source: Vital USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 52 Years

Eligibility

Inclusion Criteria:

• Subject must have the ability to understand and provide written informed consent

• Subject is adult over 18 years of age

• Subject must be willing and able to comply with study procedures and duration

• Subject is a non-smoker

• Male or female of any race

Exclusion Criteria:

Subject is considered as being morbidly obese (defined as BMI >39.5)

• Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)

• Subjects with known respiratory conditions such as:

• uncontrolled / severe asthma,

• flu,

• pneumonia / bronchitis,

• shortness of breath / respiratory distress,

• respiratory or lung surgery,

• emphysema, COPD, lung disease

• Subjects with self-reported heart or cardiovascular conditions such as:

• have had cardiovascular surgery

• Chest pain (angina)

• heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia

• previous heart attack

• blocked artery

• unexplained shortness of breath

• congestive heart failure (CHF)

• history of stroke

• transient ischemic attack

• carotid artery disease

• myocardial ischemia

• myocardial infarction

• cardiomyopathy

• Self-reported health conditions as identified in the Health Assessment Form

• diabetes,

• uncontrolled thyroid disease,

• kidney disease / chronic renal impairment,

• history of seizures (except childhood febrile seizures),

• epilepsy,

• history of unexplained syncope,

• recent history of frequent migraine headaches,

• recent head injury within the last 2 months,

• Cancer / chemotherapy

• Other known health condition, should be considered upon disclosure in health assessment form

Related Conditions & MeSH terms

• Respiratory Complication

Intervention

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.

Locations

Country	Name	City	State
United States	Clinimark Laboratory Services	Louisville	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Vital USA, Inc.	Clinimark, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory Rate Accuracy Validation for the Vital USA Vital Detect Monitor.	The primary objective of this study was to compare the accuracy of device under test for the measurement of respiratory rate. The respiratory rate was measured simultaneously with EtCO2 (Reference) and the Vital USA Vital Detect monitor (Device Under Test).The endpoint of interest was accuracy as measured by the Accuracy root-mean-square (ARMS) difference between the Device Under Test (DUT) and the reference respiratory rate system (Ref) for all stable respiratory periods.	20 Seconds