Vital USA Respiratory Rate Validation In Adults

NCT ID: NCT04292639

Last Updated: 2020-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-17
• Study Completion Date: 2019-12-20

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).

Conditions

Respiratory Complication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Respiratory Rate

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.

Group Type: EXPERIMENTAL

The Vital Detect Pulse Oximeter

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

VitalDetect

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 52 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinimark, LLC

OTHER

Sponsor Role: collaborator

Vital USA, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arthur Cabrera, MD

Role: PRINCIPAL_INVESTIGATOR

Clinimark, LLC

Locations

Clinimark Laboratory Services

Louisville, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PR 2019-326

Identifier Type: -

Identifier Source: org_study_id