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Trial registered on ANZCTR


Registration number
ACTRN12620000828921p
Ethics application status
Submitted, not yet approved
Date submitted
17/04/2020
Date registered
19/08/2020
Date last updated
19/08/2020
Date data sharing statement initially provided
19/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Transcutaneous Pulse Oximetry Brain Monitoring Study
Scientific title
Study to assess accuracy of a transcutaneous brain pulse oximeter in intensive care unit patients at risk of acute neurological deterioration.
Secondary ID [1] 301035 0
None
Universal Trial Number (UTN)
Trial acronym
T-POT Study
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
acute brain injury 317088 0
Condition category
Condition code
Neurological 315253 315253 0 0
Other neurological disorders
Injuries and Accidents 316212 316212 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A brain pulse oximeter will be placed on the temples of the head by research staff working in the ICU. Monitoring will occur for at least 4 hours and to a maximum of 4 days. Adherence will be supervised by the research staff
Intervention code [1] 317342 0
Diagnosis / Prognosis
Comparator / control treatment
The brain pulse oximeter will be compared against routinely used invasive methods of brain monitoring. The primary assessment will be a comparison with cerebral perfusion pressure. A secondary comparison will be with invasive brain oxygen (PbO2) levels.
Control group
Active

Outcomes
Primary outcome [1] 323496 0
Assessment of correlation of brain pulse oximeter oxygen levels with cerebral perfusion pressure.
Timepoint [1] 323496 0
This will be assessed over a period of monitoring from 4 hours and up to 4 days
Secondary outcome [1] 382059 0
Assessment of correlation of brain pulse oximeter oxygen levels with PbO2 levels measured using a Licox probe.
Timepoint [1] 382059 0
This will be assessed over a period of monitoring from 4 hours up to 4 days
Secondary outcome [2] 384554 0
Brain pulse oximeter detection of acute neurological deteriorations.

These are defined by one or more of the following

1. Clinical examination: new focal deficit or decrease in level of consciousness (2 or more point fall in the GCS not due to change in sedatives)

2. CPP < 50 mmHg

3. Brain pO2 < 15 mmHg

4. CT, MRI, cerebral angiogram demonstration of progression of existing brain lesion or new brain lesion

5. Operative finding of new or progression of brain injury

In addition for 1, 4 and 5 must also have a new investigation or treatment or palliation commenced or max treatment level reached in response to the deterioration.
Timepoint [2] 384554 0
The CT, MRI, angiogram etc are undertaken as part or routine care. If undertaken this data is collected at day 4 of the study.

Eligibility
Key inclusion criteria
Acute brain injury demonstrated on imaging requiring intensive care admission with mechanical ventilation

Complex brain surgery requiring intensive care admission with mechanical ventilation

Cardiac or respiratory arrest with presumed hypoxic brain injury requiring intensive care admission with mechanical ventilation

Expected to require mechanical ventilation all of today and tomorrow

Has or likely to need intra-cranial pressure monitoring

Age >18yrs.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Skin or skull trauma, precluding brain PPG signal from either hemisphere.

No cortical area suitable for brain PPG signal due to severely damage brain or cortical haematoma or other fluid under the skull from either hemisphere

Unlikely to be possible to collect at least 4 hours of data due to patient or other factors.

Non-survivable injury or no intention for aggressive intervention in the opinion of the investigator.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
we will have a single group and correlate 2 methods of brain oxygen measurement
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Bland Altman analysis of accuracy

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17052 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 30723 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 305477 0
Commercial sector/Industry
Name [1] 305477 0
Cyban Pty Ltd
Address [1] 305477 0
50 Young St Kew, Victoria, 3101
Country [1] 305477 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cyban
Address
50 Young St Kew, Victoria, 3101
Country
Australia
Secondary sponsor category [1] 305877 0
None
Name [1] 305877 0
Address [1] 305877 0
Country [1] 305877 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305793 0
St Vincents Hospital Melbourne Australia
Ethics committee address [1] 305793 0
45 Victoria Pde Fitzroy, 3065, Victoria
Ethics committee country [1] 305793 0
Australia
Date submitted for ethics approval [1] 305793 0
14/08/2020
Approval date [1] 305793 0
Ethics approval number [1] 305793 0

Summary
Brief summary
The T-POT study will assess a brain pulse oximeter designed to non-invasively monitor brain oxygen and brain blood flow in critically ill patients requiring neurological monitoring in the intensive care unit admitted with acute brain injury or at high risk of acute neurological deterioration.



The Brain Pulse Oximeter was developed to continuously measure brain oxygen levels and the brain photoplethysmogram (PPG) signal. The PPG signal detects blood volume changes in the microvascular bed of the brain and provides a relative measure of brain blood flow.



It is known that patients with an acute brain injury are at high risk of acute neurological deterioration, typically as a result of hypoperfusion in the minutes, hours or days after the initial injury. Available brain monitoring is complex expensive and highly invasive and therefore not used widely. An accurate non-invasive method to monitor brain oxygen levels and brain blood flow would facilitate earlier detection and treatment of acute neurological deteriorations, which could improve healthcare outcomes, reducing both long-term disability and death.



The major aim of the study is to assess the association of the brain pulse oximeters oxygen levels with invasive brain monitoring of cerebral perfusion pressure levels.
Trial website
Trial related presentations / publications
Public notes
Publication of trial of monitor used in a sheep model of brain injury. https://www.dovepress.com/assessment-of-a-non-invasive-brain-oximeter-in-a-sheep-model-of-acute--peer-reviewed-article-MDER

Publication of trial of monitor used in a human model of brain hypoxia. https://www.dovepress.com/assessment-of-a-non-invasive-brain-oximeter-in-volunteers-undergoing-a-peer-reviewed-article-MDER

Contacts
Principal investigator
Name 101614 0
Dr Barry Dixon
Address 101614 0
50 Young St Kew, Victoria, 3101 Cyban Pty Ltd
Country 101614 0
Australia
Phone 101614 0
+613439618815
Fax 101614 0
Email 101614 0
barry.dixon@cyban.com.au
Contact person for public queries
Name 101615 0
Dr Barry Dixon
Address 101615 0
50 Young St Kew, Victoria, 3101 Cyban Pty Ltd
Country 101615 0
Australia
Phone 101615 0
+613439618815
Fax 101615 0
Email 101615 0
barry.dixon@cyban.com.au
Contact person for scientific queries
Name 101616 0
Dr Barry Dixon
Address 101616 0
50 Young St Kew, Victoria, 3101 Cyban Pty Ltd
Country 101616 0
Australia
Phone 101616 0
+613439618815
Fax 101616 0
Email 101616 0
barry.dixon@cyban.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
concerns regarding use of this data by other commercial entities
What supporting documents are/will be available?
No other documents available
Summary results
No Results