Pulse oximeter accuracy checked in healthy adults
NCT ID NCT07201961
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study checked how accurately Nellcor pulse oximetry sensors measure oxygen levels and heart rate in 55 healthy adults aged 18 to 50. The sensors were compared to standard blood samples and ECG readings. The goal was to support market approval for these devices.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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55 people
The number who actually took part.
- Started
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Jul 2025
- Finished
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Aug 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 participants ≥ 18 and \< 51 years of age, with varying skin tones and diversity across ethnicity, race, gender, and sex assigned at birth.
- Ages
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18 to 51 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. Male or female participants ≥ 18 years of age, and \< 51 years of age. 2. Participant is willing and able to comply with study procedures and duration. 3. Participant is willing to sign an ICF. 4. Participant weighs \> 40kg (88.2 lb). 5. Participant is a non-smoker or has not smoked within 36 hours prior to the study. 6. Cleared same day health assessment form and health screening 7. Successful perfusion index ulnar/ulnar+radial ratio test (Assessed via the Allen's Test) showing adequate collateral blood flow. Exclusion Criteria: 1. Participant 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 participants to participate if the condition is noted and would not affect the sites utilized) 3. Participants 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 COHb levels \>3% as assessed by CO-Oximetry during the procedure 5. tHb \< 10 g/dl as assessed by CO-Oximetry during the procedure 6. MetHb ≥ 2% as assessed by CO-Oximetry during the procedure 7. Participants with known 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) 8. Participants with known heart or cardiovascular conditions such as: 1. Uncontrolled hypertension (systolic pressure \>140mmHg, or diastolic pressure \>90mmHg on 3 consecutive readings day of screening) 2. previous cardiovascular surgery 3. chest pain (angina) 4. heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen) 5. previous heart attack 6. blocked artery 7. unexplained shortness of breath 8. congestive heart failure (CHF) 9. history of stroke and/or transient ischemic attack 10. carotid artery disease 11. myocardial ischemia 12. myocardial infarction 13. cardiomyopathy 14. implantable active medical device such as pacemaker or automatic defibrillator 9. 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 (within the last 2 months) 8. recent symptomatic head injury (within the last 2 months) 9. cancer requiring chemotherapy, radiation, or current treatment 10. participants 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 of aspirin 16. participants 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. participants 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 10. Failure of the Allen's Test.
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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
More trials for these conditions
Other studies related to the condition(s) this trial covers.