search
Back to results

Brain Oximeter Calibration and Validation Study (TPOT)

Primary Purpose

Brain Injuries, Traumatic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
brain pulse oximeter
Sponsored by
Cyban Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Injuries, Traumatic focused on measuring hypoxia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts 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].

Sites / Locations

  • Duke Hospital Human Pharmacology & Physiology Lab

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

desaturation

Arm Description

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%.

Outcomes

Primary Outcome Measures

Accuracy of brain pulse oximeter
Bland Altman analysis

Secondary Outcome Measures

Full Information

First Posted
May 24, 2022
Last Updated
August 1, 2023
Sponsor
Cyban Pty Ltd
Collaborators
Duke University
search

1. Study Identification

Unique Protocol Identification Number
NCT05397704
Brief Title
Brain Oximeter Calibration and Validation Study
Acronym
TPOT
Official Title
Cyban Brain Pulse Oximeter Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 10, 2022 (Actual)
Primary Completion Date
November 5, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cyban Pty Ltd
Collaborators
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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 brain injury or at risk of a brain injury. 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 internal jugular venous blood gas samples are then inserted into a weighted-equation to derive the calculated brain tissue oxygen saturation. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Traumatic
Keywords
hypoxia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
desaturation
Arm Type
Experimental
Arm Description
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%.
Intervention Type
Device
Intervention Name(s)
brain pulse oximeter
Intervention Description
brain oxygen monitoring during hypoxia
Primary Outcome Measure Information:
Title
Accuracy of brain pulse oximeter
Description
Bland Altman analysis
Time Frame
Data will be collected over a 90 minute period for each patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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].
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David MacLeod, MBBS
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Hospital Human Pharmacology & Physiology Lab
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Brain Oximeter Calibration and Validation Study

We'll reach out to this number within 24 hrs