Brain Injuries, TraumaticTPOTNCT05397704
Brain Oximeter Calibration and Validation Study
A study testing brain pulse oximeter in people with Brain Injuries, Traumatic, run by Cyban Pty Ltd at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- brain pulse oximeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2022to 15 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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];
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- 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].
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Hospital Human Pharmacology & Physiology Lab
Durham, North Carolina, 27708
About this study
Official title: Cyban Brain Pulse Oximeter Study
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.
Read the 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.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- brain pulse oximeter
- Keywords
- hypoxia
- Medical subject headings
- Brain Injuries, Traumatic, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brain pulse oximeterDevice
brain oxygen monitoring during hypoxia
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: Device: brain pulse oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of brain pulse oximeter
Bland Altman analysis
Measured: Data will be collected over a 90 minute period for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start10 Oct 2022
- Primary completion5 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyban Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- David MacLeod, MBBS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397704
- Sponsor's protocol ID
- Pro00110458
- Acronym
- TPOT
- Status last verified
- Aug 2023
- First submitted
- 24 May 2022
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyban Brain Pulse Oximeter Study
- ClinicalTrials.gov ID
- NCT05397704
- Acronym / sponsor ID
- TPOT / Pro00110458
- Conditions
- Brain Injuries, Traumatic
- Keywords
- hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Cyban Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Duke University
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 5 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment
| Arm | Type | Receives |
|---|---|---|
| desaturation | Experimental | Device: brain pulse oximeterControlled 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%. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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];
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brain pulse oximeterbrain oxygen monitoring during hypoxia | Device | desaturation |
Primary outcome
Accuracy of brain pulse oximeter
Time frame: Data will be collected over a 90 minute period for each patient
Bland Altman analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David MacLeod, MBBS principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brain pulse oximeter in people with Brain Injuries, Traumatic, run by Cyban Pty Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of brain pulse oximeter (time frame: Data will be collected over a 90 minute period for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.