Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry

Completed · Not applicable

Conditions studied: Arterial Disease

In brief

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

Key facts

Study ID

NCT04285411

Run by

Vital USA, Inc.

People needed

10

Starts

2019-11-04

Expected to finish

2019-11-20

Last updated by the study team

2020-06-02

Who can join

Age: 18 and older, up to 52. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinimark Laboratory Services — Louisville, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.