Hypoxia Clinical Trial
Official title:
SpO2 Accuracy Validation of the OxySoft Sensor Via Reference CO-Oximetry, During Motion and Non-Motion Conditions in Healthy, Well-Perfused Subjects
Verified date | October 2020 |
Source | Medtronic - MITG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
SpO2 (oxygen saturation) and pulse rate accuracy of pulse oximetry equipment, OxySoft Sensor/N-600x and OxySoft Sensor/N-395, continuous measure of arterial oxygen saturation during hypoxic state throughout motion and non-motion conditions under one system configuration. The purpose of this Non-Randomized, Prospective,Observational study is to conduct a hypoxia study to directly compare a prototype OxySoft pulse oximeter system to arterial oxygen saturation.
Status | Completed |
Enrollment | 16 |
Est. completion date | August 21, 2020 |
Est. primary completion date | August 21, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: 1. Subject must have the ability to understand and provide written informed consent 2. Adult subjects 18 to 50 years of age. 3. Subject must be willing and able to comply with study procedures and duration. 4. Subject is a non-smoker or who has not smoked within 2 days prior to the study. 5. Male or female of any race. 6. Cleared same day Health Assessment form and health screening. 7. Subject demographics include a range of skin pigmentations, including at least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger. 8. Successful Perfusion Index Ulnar/Ulnar+Radial Ratio test showing adequate collateral blood flow. Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from the study: 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. Females 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. Subjects with known respiratory conditions such as: 1. uncontrolled / severe asthma, 2. flu, 3. pneumonia / bronchitis, 4. shortness of breath / respiratory distress, 5. unresolved respiratory or lung surgery, 6. emphysema, COPD, lung disease 8. 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 or 5. with respiratory sinus arrhythmia 6. previous heart attack 7. blocked artery 8. unexplained shortness of breath 9. congestive heart failure (CHF) 10. history of stroke 11. transient ischemic attack 12. carotid artery disease 13. myocardial ischemia 14. myocardial infarction 15. cardiomyopathy 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, 8. recent symptomatic head injury, within the last 2 months 9. Subjects with known clotting disorders 10. history of bleeding disorders or personal history of prolonged bleeding from injury 11. history of blood clots 12. hemophilia 13. current use of blood thinner: prescription or daily use of aspirin 14. 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 15. Subjects with prior or known severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain) or heparin 16. Arterial cannulation within the last 30 days prior to study date, (this may exclude only one radial artery site. left or right) 17. History of clinically significant complications from previous arterial cannulation. 18. A radial artery with ten or more arterial cannulations right or left, excludes that site. 19. Unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits. 20. Other known health condition, should be considered upon disclosure in Health Assessment form |
Country | Name | City | State |
---|---|---|---|
United States | Clinimark | Louisville | Colorado |
Lead Sponsor | Collaborator |
---|---|
Medtronic - MITG |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To investigate performance of the OxySoft device by measuring oxygen saturation accuracy during motion and non-motion conditions | The primary objective of the study is to investigate the efficacy and performance of the OxySoft device by measuring oxygen saturation accuracy in a diverse subject population during motion and non-motion conditions and over a specified saturation range.
The acceptance criteria for SpO2, on the non-motion hand, across the saturation range of 70-100% when paired with the N-395: SpO2 OxySoft Sensor/N-395 ± 3% (Arms) The acceptance criteria for SpO2 during motion conditions, on the motion hand, across the saturation range of 70-100% when paired with the N-600x: SpO2 OxySoft Sensor/N-600x ± 3% (Arms) |
October 2020 | |
Primary | To investigate efficacy and performance of OxySoft device by measuring pulse rate accuracy during motion and non-motion conditions | The secondary objective of the study is to investigate the efficacy and performance of the OxySoft device by measuring pulse rate accuracy in a diverse subject population during motion and non-motion conditions and over a specified saturation range.
The acceptance criteria for pulse rate during motion conditions, on the motion hand, across the saturation range of 70-100% when paired with the N-600x: PR OxySoft Sensor/N-600x = 5 BPM |
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