Arterial Disease Clinical Trial
Official title:
Results of the SpO2 and Pulse Rate Accuracy Comparison of VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG
Verified date | May 2020 |
Source | Vital USA, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Clinical Investigation Plan: Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry Study ID# PR 2019-353, Version: Rev 1, Date: 15 Oct 2019 Study Dates: November 4-5, 2019
Status | Completed |
Enrollment | 10 |
Est. completion date | November 20, 2019 |
Est. primary completion date | November 5, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 52 Years |
Eligibility |
Inclusion Criteria 1. 10-15 Adults with a minimum of 3 males and a minimum of 3 females, with the balance made up of either 2. Subject must have the ability to understand and provide written informed consent 3. Subject is 18 to 50 years of age 4. Subject must be willing and able to comply with study procedures and duration 5. Subject is a non-smoker or who has not smoked within 2 days prior to the study Exclusion Criteria 1. Subject is considered as being morbidly obese (defined as BMI >39.5). 2. Compromised circulation, injury, or physical malformation of fingers, wrist, 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.) 3. Female subjects that are actively trying to get pregnant or are pregnant (confirmed by positive urine pregnancy test unless the subject is known to be not of child-bearing potential). 4. Smoker Subjects who have refrained will be screened for COPD levels >3% as assessed with a Radical 7 (Rainbow) 5. Subjects with known respiratory conditions such as: (self-reported): 1. uncontrolled / severe asthma, 2. flu, 3. pneumonia / bronchitis, 4. shortness of breath / respiratory distress, 5. unresolved respiratory or lung surgery with continued indications of health issues, 6. emphysema, COPD, lung disease. 6. Subjects with known heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review) 1. hypertension: systolic >140mmHg, Diastolic >90mmHg on 3 consecutive readings (reviewed during health screen). 2. have had cardiovascular surgery 3. Chest pain (angina) 4. heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen) 5. previous heart attack 6. blocked artery 7. unexplained shortness of breath 8. congestive heart failure (CHF) 9. history of stroke 10. transient ischemic attack 11. carotid artery disease 12. myocardial ischemia 13. myocardial infarction 14. cardiomyopathy 7. Self-reported health conditions as identified in the Health Assessment Form (self-reported) 1. diabetes, 2. uncontrolled thyroid disease, 3. kidney disease / chronic renal impairment, 4. history of seizures (except childhood febrile seizures), 5. epilepsy, 6. history of unexplained syncope, 7. recent history of frequent migraine headaches, 8. recent symptomatic head injury (within the last 2 months) 9. cancer / chemotherapy 8. Subjects with known clotting disorders (self-reported) |
Country | Name | City | State |
---|---|---|---|
United States | Clinimark Laboratory Services | Louisville | Colorado |
Lead Sponsor | Collaborator |
---|---|
Vital USA, Inc. | Clinimark, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate SpO2 Accuracy Per Standards for Pulse Oximetry. | This study was a comparative, single-center, non-randomized study conducted to evaluate the SpO2 accuracy per standards and guidelines identified above for SpO2 accuracy for pulse oximetry equipment over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison. As a secondary goal, the pulse rate accuracy was compared to ECG Heart Rate realized over the range throughout the hypoxia procedure. Testing was conducted under normal office environment conditions. | 90 Seconds | |
Secondary | The Pulse Rate Accuracy Compared to ECG Heart Rate. | The pulse rate accuracy was compared to ECG Heart Rate as recorded by the S5 Multi-parameter monitor. Passing criteria was an ARMS of 3 bpm or better based measurements observed during the pulse oximetry evaluation. | 90 Seconds |
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