SpO2 Accuracy Comparison of Medline ReNewal Sensors to Arterial Blood CO-Oximetry
Completed · Not applicable
Conditions studied: Arterial Oxygen Saturation, Healthy
In brief
The purpose of this clinical study is to validate the SpO2 accuracy of the Medline ReNewal pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the ReNewal sensors. It is required that the Accuracy Root Mean Square (ARMS) performance of the ReNewal pulse oximetry sensors will meet a specification of 3 or better in non-motion conditions for the range of 70 - 100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.
Key facts
- Study ID
- NCT03565679
- Run by
- Medline Industries
- People needed
- 10
- Starts
- 2018-05-09
- Expected to finish
- 2018-05-10
- Last updated by the study team
- 2019-06-18
Who can join
Age: 18 and older, up to 50. 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, 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.)
- Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
- Smoker Subjects who have refrained will be screened for COHb levels >3% as assessed with a Masimo Radical 7 (Rainbow)
- Subjects with known respiratory conditions such as: (self-reported)
- uncontrolled / severe asthma,
- flu,
- pneumonia / bronchitis,
- shortness of breath / respiratory distress,
- respiratory or lung surgery,
- emphysema, chronic obstructive pulmonary disease (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 Desaturation Laboratory, Site ID# 001 — Louisville, Colorado, United States
Full record on ClinicalTrials.gov
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