Respiratory Complication
Conditions
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).
Interventions
DEVICEThe 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.
Sponsors
Clinimark, LLC
Vital USA, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 52 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
The final study population consisted of 20 qualified healthy subjects, 10 males and 10 females, ranging in age from 18 to 52 yrs of any racial / ethnic background. Each subject understood the study and provided consent for participation by signing the Independent Review Board (IRB) approved Informed Consent Form prior to start of the test.
Pre-assignment details
The subjects were healthy showing no evidence of significant medical problems as indicated by satisfactorily completing the health assessment form. Eligible subjects needed to meet all of the inclusion criteria and none of the exclusion criteria for participation.
Participants by arm
| Arm | Count |
|---|---|
| Respiratory Rate This study was a comparative, single-center, non-randomized, parallel study, conducted on 20 subjects. The acceptance criteria in this study used a comparison of the Vital USA Vital Detect to a reference Respiratory Rate EtCO2 monitor. Testing was conducted under normal office environment conditions. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Respiratory Rate |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 29.3 years STANDARD_DEVIATION 10.5 |
| BMI | 23.5 lbs/sq.In. STANDARD_DEVIATION 2.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitzpatrick Scale Type II Fair Skin Blue Eyes | 12 Participants |
| Fitzpatrick Scale Type III Darker White Skin | 3 Participants |
| Fitzpatrick Scale Type I Pale White Skin Blue/Green Eyes | 3 Participants |
| Fitzpatrick Scale Type IV Brown Skin | 0 Participants |
| Fitzpatrick Scale Type V Dark Brown Skin | 1 Participants |
| Fitzpatrick Scale Type VI Black Skin | 1 Participants |
| Height | 67.3 In STANDARD_DEVIATION 3.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
| Weight | 151.9 Lbs STANDARD_DEVIATION 25.9 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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.
Time frame: 20 Seconds
Population: The final study population consisted of 20 qualified healthy subjects, 10 males and 10 females, ranging in age from 18 to 52 years and of any racial / ethnic background.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respiratory Rate | Respiratory Rate Accuracy Validation for the Vital USA Vital Detect Monitor. | 1.39 Breaths/Min | Standard Deviation 1.39 |