Vital USA Respiratory Rate Validation In Adults

Not Applicable

Completed

• Conditions: Respiratory Complication
• Interventions: Device: The Vital Detect Pulse Oximeter

• Registration Number: NCT04292639
• Lead Sponsor: Vital USA, Inc.

Brief 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).

Study Timeline

• Study Start: 2019-12-17
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Study First Submitted: 2020-02-21
• Study First Submitted QC: 2020-02-28
• Study First Posted: 2020-03-03
• Results First Submitted: 2020-03-11
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-20
• Last Update Submitted: 2020-05-20
• Results First Posted: 2020-05-28
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Respiratory Rate	The Vital Detect Pulse Oximeter	The purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the Vital USA Vital Detect to an FDA cleared End Tidal Carbon Dioxide monitor Reference Standard (GE Datex-Ohmeda). This report documents exclusively the results of the Respiratory Rate accuracy performance for the Vital USA Vital Detect.

Primary Outcome Measures

Name	Time	Method
Respiratory Rate Accuracy Validation for the Vital USA Vital Detect Monitor.	20 Seconds	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.

Trial Locations

Locations (1)

Clinimark Laboratory Services; 🇺🇸 Louisville, Colorado, United States