OM2 Abbreviated Sensor Verification

Completed

Conditions studied: Hypoxia

In brief

The verification of an investigational pulse oximetry board to verify pulse rate and saturation accuracy over a specified saturation range in diverse populations.

Key facts

Study ID

NCT06415799

Run by

Medtronic - MITG

People needed

28

Starts

2024-02-11

Expected to finish

2024-02-22

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female subjects 18 to 50 years of age
• Subject is willing and able to comply with study procedures and duration
• Subject is willing to sign an informed consent
• Subject weighs >40kg
• Subject is a non-smoker or has not smoked within 2 days prior to the study
• Cleared same day health assessment form and health screening
• 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
• recent COVID (last 2 months)
• 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 (reviewed during health screen)
• previous heart attack
• blocked artery
• unexplained shortness of breath
• congestive heart failure (CHF)
• history of stroke
• transient ischemic attack

Where it is running

• Element — Louisville, Colorado, United States

Full record on ClinicalTrials.gov

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