Hypoxia
Conditions
Keywords
Low Saturation, Pulse Oximetry
Brief summary
The verification of an investigational pulse oximetry board to verify pulse rate and saturation accuracy over a specified saturation range in diverse populations.
Detailed description
To verify the SpO2 and pulse rate accuracy in comparison to a reference standard blood measurements. To achieve paired observations of SpO2 and SaO2 values over the specified SpO2 accuracy range of the prototype pulse oximeter on a group of healthy adult volunteers. The fraction of inspired oxygen (FiO2) delivered to test subjects is varied to achieve a series of targeted steadystate saturation periods. In this study, the investigational pulse oximetry PCBA system saturation measurements will be compared to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from a diverse pool of healthy human subjects.
Interventions
None listed
Sponsors
Medtronic - MITG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verification of Saturation Accuracy | 2.5 hours | Verification of Saturation Accuracy Saturation accuracy in a diverse subject population over a specified saturation range. The acceptance criteria for SpO2 during low saturation conditions across the saturation range of 60-80%: SpO2 Max-A ±3% (ARMS) Max-N ±3% (ARMS) OxySoft-N ±3% (ARMS) Max-Fast ±3%(ARMS) |
| Acceptance criteria for SpO2 accuracy across the saturation range of 70-100%: | 2.5 hours | Verification of Saturation Accuracy Saturation accuracy in a diverse subject population over a specified saturation range. The acceptance criteria for SpO2 during saturation conditions across the saturation range of 70-100%: SpO2 Max-A ±2% (ARMS) Max-N ±2% (ARMS) OxySoft-N ±2% (ARMS) Max-Fast ±2%(ARMS) |
| Acceptance criteria for pulse rate accuracy within 20-250 BPM | 2.5 hours | Pulse rate accuracy Max-A \<=3 BPM (ARMS) Max-N \<=3 BPM (ARMS) OxySoft-N \<=3 BPM (ARMS) Max-Fast \<=3 BPM(ARMS) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRandall M Clark
Medtronic Clinical Physiology Laboratory
PRINCIPAL_INVESTIGATORDavid Macleod
Duke University
Outcome results
None listed