N600X Low Saturation Accuracy Validation

Completed

Conditions studied: Hypoxia

In brief

To compare pulse oximetry 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

NCT05532670

Run by

Medtronic - MITG

People needed

15

Starts

2022-09-29

Expected to finish

2022-11-01

Last updated by the study team

2022-11-23

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
• 2 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.
• Any gender 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 with sickle cell disease.
• 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 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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