Stopped: The decision was made to withdraw this study prior to recruitment to make further changes to the investigational device.
0Started 2025-09-06
Plain-language summary
The purpose of this study is to calibrate and validate a cerebral oximeter product from Cyban Pty. Ltd. The study will involve comparing cerebral oximeter signals against reference arterial and jugular bulb blood gas measures.
Who can participate
Age range18 Years – 45 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 a…