Status:
COMPLETED
Brain Oximeter Calibration and Validation Study
Lead Sponsor:
Cyban Pty Ltd
Collaborating Sponsors:
Duke University
Conditions:
Brain Injuries, Traumatic
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
The purpose of the study is to calibrate and to validate the accuracy of the oximeter with an estimate of brain oxygen levels assessed by measuring arterial and internal jugular vein blood oxygen satu...
Detailed Description
The device is a non invasive NIRS monitor. It detects signals from which are derived venous and arterial blood brain oxygen levels. The device will be used as a adjunct monitor in patients with a bra...
Eligibility Criteria
Inclusion
- Healthy, male or female subjects between the ages of 18 to 45 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 - 35.0;
- Assigned American Society of Anesthesiologists (ASA) Physical Status 1 by Principal Investigator or delegate
Exclusion
- 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 breast feeding;
- Has anemia \[lab values specific for gender\];
- Has heparin allergy
- Has a history of sickle cell trait or thalassemia \[self-reported\];
- Has an abnormal hemoglobin electrophoresis result \[lab measurement\];
- Has a positive urine cotinine test or urine drug screen or oral ethanol test;
- Has a room air saturation less than 95% by pulse oximetry \[measurement by PI or delegate\]
- Has a clinically significant abnormal EKG \[assessment by PI or delegate\];
- 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% \[measured by venous blood sample co- oximetry\].
Key Trial Info
Start Date :
October 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05397704
Start Date
October 10 2022
End Date
November 15 2022
Last Update
August 2 2023
Active Locations (1)
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1
Duke Hospital Human Pharmacology & Physiology Lab
Durham, North Carolina, United States, 27708