Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06657820 | NOT YET RECRUITING | Hypoxia

Optical Brain Pulse Monitor: Validation of Cerebral Oximetry Monitoring (OBPM:VOCOM) Study.
Sponsor:

Elliot Teo

Information provided by (Responsible Party):

Elliot Teo

Brief 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.

Condition or disease

Hypoxia

Intervention/treatment

Hypoxia in healthy individuals

Cerebral Oximetry

Blood Gas Sampling

Phase

NA

Detailed Description:

The primary objective of the study is to measure the absolute and relative accuracy of the StO2 device by comparing the NIRS-derived brain tissue oxygen saturation with blood-referenced CO-oximeter oxygen saturation values. The CO-oximeter oxygen saturation values from paired arterial and jugular bulb blood samples are combined into a weighted-equation to derive the reference SavO2. Accuracy is reported over a range of oxygen saturations with study subjects exposed to a controlled oxygen desaturation with serial sampling of paired arterial and internal jugular venous blood gas samples.

Study Type : INTERVENTIONAL
Estimated Enrollment : 65 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Optical Brain Pulse Monitor: Validation of Cerebral Oximetry Monitoring (OBPM: VOCOM) Study.
Actual Study Start Date : 2025-01-06
Estimated Primary Completion Date : 2025-04-30
Estimated Study Completion Date : 2025-05-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 45 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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 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% \[measured by venous blood sample co- oximetry\].
  • * Students and Employees under the direct supervision of PI or Sub-I.
Optical Brain Pulse Monitor: Validation of Cerebral Oximetry Monitoring (OBPM:VOCOM) Study.

Location Details

NCT06657820

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

No Location Found