Brain Oximeter Calibration and Validation Study

NCT05397704 | Completed FDA Device

• 1 other identifier: Pro00110458
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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 saturations.

Conditions

Brain Injuries, Traumatic

Keywords

hypoxia

Outcome Measures

Primary Outcomes (1)

• Accuracy of brain pulse oximeter

  Bland Altman analysis

  Data will be collected over a 90 minute period for each patient

Study Arms (1)

desaturation

EXPERIMENTAL

Controlled desaturation studies are conducted by changing the alveolar oxygen tension (or pressure, PAO2). This is achieved by a dedicated gas delivery system, RespirAct RAMR (Thornhill Research, Toronto, ON). The attained PAO2 then determines the arterial oxygen tension (PaO2) at the alveolar-arterial interspace in the lung. The arterial oxygen tension (PaO2) will then determine the arterial oxygen saturation (SaO2) and in turn, the pulse oximeter oxygen saturation (SpO2). The step down changes in the alveolar oxygen tension (PAO2) will result in the corresponding step down changes in SaO2/SpO2 from 100 to 70%.

Device: brain pulse oximeter

Interventions

brain pulse oximeter DEVICE

brain oxygen monitoring during hypoxia

desaturation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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 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 \[assessment by PI or delegate\];

Sponsors & Collaborators

• Cyban Pty Ltd: lead
• Duke University: collaborator

Study Sites (1)

Duke Hospital Human Pharmacology & Physiology Lab

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Hypoxia

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David MacLeod, MBBS

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group assignment

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 31, 2022
• Study Start: October 10, 2022
• Primary Completion: November 5, 2022
• Study Completion: November 15, 2022
• Last Updated: August 2, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)