Status:
COMPLETED
Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry
Lead Sponsor:
Vital USA, Inc.
Collaborating Sponsors:
Clinimark, LLC
Conditions:
Arterial Disease
Eligibility:
All Genders
18-52 years
Phase:
NA
Brief Summary
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
Detailed Description
An SpO2 accuracy comparison was conducted as part of the final validation of the VitalDetect™ pulse oximetry system. The study was conducted in accordance to Code of Federal Regulations (CFR) for Non-...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 10-15 Adults with a minimum of 3 males and a minimum of 3 females, with the balance made up of either
- Subject must have the ability to understand and provide written informed consent
- Subject is 18 to 50 years of age
- Subject must be willing and able to comply with study procedures and duration
- Subject is a non-smoker or who has not smoked within 2 days prior to the study
- Exclusion Criteria
- Subject is considered as being morbidly obese (defined as BMI \>39.5).
- 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.)
- 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).
- Smoker Subjects who have refrained will be screened for COPD levels \>3% as assessed with a Radical 7 (Rainbow)
- Subjects with known respiratory conditions such as: (self-reported):
- uncontrolled / severe asthma,
- flu,
- pneumonia / bronchitis,
- shortness of breath / respiratory distress,
- unresolved respiratory or lung surgery with continued indications of health issues,
- emphysema, COPD, lung disease.
- Subjects with known heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review)
- hypertension: systolic \>140mmHg, Diastolic \>90mmHg on 3 consecutive readings (reviewed during health screen).
- have had cardiovascular surgery
- Chest pain (angina)
- heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
- 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 (self-reported)
- 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 symptomatic head injury (within the last 2 months)
- cancer / chemotherapy
- Subjects with known clotting disorders (self-reported)
Exclusion
Key Trial Info
Start Date :
November 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04285411
Start Date
November 4 2019
End Date
November 20 2019
Last Update
June 2 2020
Active Locations (1)
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1
Clinimark Laboratory Services
Louisville, Colorado, United States, 80027