Validation of Next Generation Cerebral and Tissue Oximeter

Validation of Next Generation INVOS NIRS Cerebral and Tissue Oximeter to Measure Cerebral and Somatic Tissue Oxygen Saturation in Healthy Volunteers

This is a validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation.

Inclusion Criteria:

1. Healthy, male or female subjects between the ages of 18 to ≤46 years;
2. Completion of a health screening for a medical history by a licensed physician, nurse practitioner or physician assistant;
3. Minimum weight 40kg;
4. BMI within range 18.0 - 30.0.

Exclusion Criteria:

1. Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) [self-reported];
2. Prior known severe allergies to medical grade adhesive/tape (Band-Aid) [self-reported];
3. Taking any medication other than birth control [self-reported];
4. Is currently participating in, or has recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational drug, device, or biologic study [self-reported];
5. Has a negative Allen's Test to confirm non-patency of the collateral artery [clinical assessment by PI or delegate];
6. Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure [self-reported];
7. Is female with a positive pregnancy test [serum or urine], or is female and is unwilling to use effective birth control between the time of screening and study procedure or is breastfeeding;
8. Has anemia [lab values specific for gender];
9. Has a history of sickle cell trait or thalassemia [self-reported];
10. Has an abnormal hemoglobin electrophoresis test [lab measurement];
11. Has a positive urine cotinine test or urine drug screen or oral ethanol test [POC testing];
12. Has a room air saturation less than 95% by pulse oximetry [measurement by PI or delegate];
13. Has a clinically significant abnormal ECG [assessment by PI or delegate];
14. Has a clinically significant abnormal pulmonary function test via spirometry [assessment by PI or delegate];
15. Has a COHb greater than 3%, or MetHb greater than 2% [measured by venous blood sample co-oximetry]