Verification of a new pulse oximeter for measuring oxygen levels

Low Saturation Verification of Investigational Pulse Oximetry Devices in Adult Volunteers

This study is testing a new pulse oximeter to see if it accurately measures oxygen levels in healthy adults compared to standard blood tests.

Quick facts

• Study type: Observational
• Enrollment: 24 (estimated)
• Ages: 18 Years to 39 Years
• Sex: All
• Sponsor: Medtronic - MITG (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Denver, Colorado)
• Trial ID: NCT06661889 on ClinicalTrials.gov

What this trial studies

This study aims to verify the accuracy of a new investigational pulse oximetry device by comparing its measurements of blood oxygen saturation (SpO2) and pulse rate against a reference standard using arterial blood samples. Healthy adult volunteers will participate, with varying levels of oxygen delivered to achieve different saturation levels. The goal is to assess the device's performance across a specified saturation range in a diverse population. The study will involve paired observations of the investigational device and a multi-wavelength CO-oximeter.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 39 who meet specific health criteria.

Not a fit: Patients with morbid obesity, compromised circulation, or active respiratory conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved accuracy in pulse oximetry measurements, enhancing patient monitoring and care.

How similar studies have performed: While this approach is focused on verifying a new device, similar studies have shown success in validating pulse oximetry technologies.

Eligibility criteria

Inclusion Criteria:

1. Healthy volunteers 18 to ≤39 years
2. Subject is willing and able to comply with study procedures and duration
3. Subject is willing to sign an informed consent
4. Subject weighs \>40kg
5. Subject is a non-smoker or has not smoked within 2 days prior to the study
6. Cleared same day health assessment form and health screening

Exclusion Criteria:

1. Subject is considered as being morbidly obese (defined as BMI \>39.5)
2. 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)
3. Subjects 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
4. Subjects with known concurrent, active respiratory conditions such as:

   1. uncontrolled / severe asthma
   2. flu or influenza type infection
   3. pneumonia / bronchitis
   4. shortness of breath / respiratory distress
   5. unresolved respiratory or lung surgery
   6. emphysema, COPD, lung disease
   7. recent COVID (last 2 months)
5. Subjects with known heart or cardiovascular conditions such as:

   1. hypertension: systolic \>140mmHg, or Diastolic \>90mmHg on 3 consecutive readings
   2. have had cardiovascular surgery
   3. chest pain (angina)
   4. heart rhythms other than a normal sinus rhythm and/or with respiratory sinus arrhythmia, at the discretion of the Principal Investigator or designee
   5. previous heart attack
   6. blocked artery
   7. unexplained shortness of breath
   8. congestive heart failure (CHF)
   9. history of stroke
   10. transient ischemic attack
   11. carotid artery disease
   12. myocardial ischemia
   13. myocardial infarction
   14. cardiomyopathy
   15. implantable active medical device such as pacemaker or automatic defibrillator
6. Self-reported health conditions as identified in the Health Assessment Form

   1. diabetes
   2. uncontrolled thyroid disease
   3. kidney disease / chronic renal impairment
   4. history of seizures (except childhood febrile seizures)
   5. epilepsy
   6. history of unexplained syncope
   7. recent history of frequent migraine headaches
   8. recent symptomatic head injury, within the last 2 months
   9. cancer requiring chemotherapy, radiation, or current treatment
   10. subjects with known clotting disorders
   11. history of bleeding disorders or personal history of prolonged bleeding from injury
   12. history of blood clots
   13. hemophilia
   14. sickle cell trait or disease
   15. current use of blood thinner: prescription or daily use such as aspirin
   16. subjects with Severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors
   17. participants with severe allergy to iodine (only applicable if iodine is used)
   18. subjects with prior or known severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain) or heparin
   19. arterial cannulation within the last 30 days prior to study date, (this may exclude only one radial artery site, left or right)
   20. history of clinically significant complications from previous arterial cannulation
   21. unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits
   22. other known health condition, upon disclosure in Health Assessment form

Where this trial is running

Denver, Colorado

• Medtronic Clinical Physiology Lab — Denver, Colorado, United States (Recruiting)

Study contacts

• Principal investigator: Randall M Clark — Medtronic Clinical Physiology Laboratory
• Study coordinator: Stacy Osborn

Conditions Hypoxia; Low Saturation; Pulse Oximetry