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

Elliot Teo

Status: Withdrawn

Conditions: Hypoxia

Treatments: Diagnostic Test: Blood Gas Sampling; Procedure: Hypoxia in healthy individuals; Device: Cerebral Oximetry

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06657820

Pro00116391

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Desaturation

Experimental group

Description:

A central venous catheter will be placed in the right internal jugular vein and the catheter tip advanced retrograde to lie at the level of the jugular bulb. An arterial catheter will be placed in the forearm. A dedicated breathing circuit will be used to reduce the alveolar oxygen tension (PAO2) in stepwise fashion to produce a controlled oxygen desaturation sequence. The dedicated breathing circuit will be used to maintain the alveolar carbon dioxide tension (PACO2) at normocapnic value of 40 mmHg. At each step once steady state conditions are achieved, serial paired arterial and jugular bulb venous samples will be drawn. The blood gas samples will be analyzed by Radiometer ABL90 Flex CO-oximeter.

Treatment:

Device: Cerebral Oximetry

Procedure: Hypoxia in healthy individuals

Diagnostic Test: Blood Gas Sampling