New pulse oximeters put to the test in Low-Oxygen study
NCT ID NCT06661889
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed study tested how accurately new pulse oximeters measure oxygen levels and heart rate in healthy adults. Researchers lowered oxygen levels in 28 volunteers to check the devices' performance in the 60-80% range. The goal was to see if the devices meet strict accuracy standards.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to more accurate pulse oximeters for patients with low oxygen levels.
- What could go wrong
- This was a small, early-stage verification study in healthy volunteers, not patients. Real-world performance may differ.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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28 people
The number who actually took part.
- Started
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Nov 2024
- Finished
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May 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Healthy Male or Female volunteers age 18 to 39 years, weighing greater than 40kgs. Volunteers must be non-smokers or not smoked within 2 days prior to the study. Cleared a same day health assessment form and health screen to ensure none of the exclusion criteria was met. With a successful perfusion index ulnar/ulnar+radial ratio test showing adequate collateral blood flow.
- Ages
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18 to 39 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Medtronic Clinical Physiology Lab
Denver, Colorado, 80218, United States
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