N/A
N=10
Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry
Arterial Disease
Bottom Line
View on ClinicalTrials.gov: NCT04285411 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Evaluate SpO2 Accuracy Per Standards for Pulse Oximetry. — 3.1 percent
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Accuracy of the VitalDetect™ pulse oximetry system (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vital USA, Inc.
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate SpO2 Accuracy Per Standards for Pulse Oximetry. |
3.1 | — |
| SECONDARY The Pulse Rate Accuracy Compared to ECG Heart Rate. |
2.7 | — |
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
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04285411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.