SpO2 Accuracy Low Saturation Validation of the OxySoftN Sensor
Completed
Conditions studied: Hypoxia, Desaturation of Blood
In brief
To compare prototype pulse oximeter saturation measurements, during normal to low saturation, to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from healthy human subjects.
Key facts
- Study ID
- NCT04811963
- Run by
- Medtronic - MITG
- People needed
- 10
- Starts
- 2021-04-06
- Expected to finish
- 2021-04-09
- Last updated by the study team
- 2021-05-18
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subject must have the ability to understand and provide written informed consent
- Adult subjects 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.
- Male or female of any race.
- Cleared same day Health Assessment form and health screening.
- Cleared physical exam by a licensed physician, physician assistant, or advanced practice nurse (medical exam includes 12-lead ECG, medical history and blood test to show no sickle cell disease present)
- Successful Perfusion Index Ulnar/Ulnar+Radial Ratio test showing adequate collateral blood flow.
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, 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 sites utilized.)
- Females of childbearing potential, who are pregnant, who are trying to get pregnant or who have a urine test positive for pregnancy on the day of the study
- Subjects with COHb levels >3% as assessed by CO-Oximetry during the procedure
- tHb < 10 g/dl as assessed by CO-Oximetry during the procedure
- MetHb ≥ 2% as assessed by CO-Oximetry during the procedure
- Subjects with known respiratory conditions such as:
- uncontrolled / severe asthma,
- flu or influenza type infection
- pneumonia / bronchitis,
- shortness of breath / respiratory distress,
- unresolved respiratory or lung surgery,
- emphysema, COPD, lung disease
- Subjects with known heart or cardiovascular conditions such as:
- Hypertension: systolic >140mmHg, or Diastolic >90mmHg on 3 consecutive readings.
- have had cardiovascular surgery
- Chest pain (angina)
- heart rhythms other than a normal sinus rhythm or
- with respiratory sinus arrhythmia
- previous heart attack
- blocked artery
- unexplained shortness of breath
- congestive heart failure (CHF)
- history of stroke
- transient ischemic attack
Where it is running
- Clinimark — Louisville, Colorado, United States
Full record on ClinicalTrials.gov
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