Oxygen Saturation Measurement
Conditions
Keywords
Hypoxia, Pulse Oximetry, Healthy Volunteer
Brief summary
To collect data on a variety of market approved Nellcor™ pulse oximetry sensors with the Nellcor™ Pulse Oximetry device to support the market approval.
Detailed description
The purpose of this study is to collect data on the Nellcor™ Pulse Oximetry device when paired with a variety of Nellcor™ Market Released sensors under invasive, controlled desaturation conditions, to verify Pulse Rate and SpO2 accuracy in a diverse participant population over a specified saturation range.
Interventions
None listed
Sponsors
Medtronic - MITG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 51 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of pulse rate accuracy | 2 - 3 hours | Performance will be determined by calculating the accuracy in terms of root mean square difference (ARMS) comparing the pulse rate measurement from the Nellcor Pulse Oximetry device to the heart rate measurements as obtained by ECG. |
| Evaluation of saturation accuracy | 2-3 Months | Performance will be determined by calculating the accuracy in terms of root mean square difference (ARMS) comparing the noninvasive oxygen saturation measurement (SpO2) to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample. |
Countries
United States
Outcome results
None listed