Validation of Next Generation Cerebral and Tissue Oximeter
Completed · Not applicable
Conditions studied: Oxygen Deficiency
In brief
This is a validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation.
Key facts
- Study ID
- NCT03128372
- Run by
- Medtronic - MITG
- People needed
- 32
- Starts
- 2017-05-22
- Expected to finish
- 2017-07-19
- Last updated by the study team
- 2018-11-09
Who can join
Age: 18 and older, up to 46. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy, male or female subjects between the ages of 18 to ≤46 years;
- Completion of a health screening for a medical history by a licensed physician, nurse practitioner or physician assistant;
- Minimum weight 40kg;
- BMI within range 18.0 - 30.0.
You may not qualify if…
- Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) [self-reported];
- Prior known severe allergies to medical grade adhesive/tape (Band-Aid) [self-reported];
- Taking any medication other than birth control [self-reported];
- 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];
- Has a negative Allen's Test to confirm non-patency of the collateral artery [clinical assessment by PI or delegate];
- 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];
- 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;
- Has anemia [lab values specific for gender];
- Has a history of sickle cell trait or thalassemia [self-reported];
- Has an abnormal hemoglobin electrophoresis test [lab measurement];
- Has a positive urine cotinine test or urine drug screen or oral ethanol test [POC testing];
- Has a room air saturation less than 95% by pulse oximetry [measurement by PI or delegate];
- Has a clinically significant abnormal ECG [assessment by PI or delegate];
- Has a clinically significant abnormal pulmonary function test via spirometry [assessment by PI or delegate];
- Has a COHb greater than 3%, or MetHb greater than 2% [measured by venous blood sample co-oximetry]
Where it is running
- Duke University Hospital, HPPL — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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