Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000828921
Ethics application status
Approved
Date submitted
17/04/2020
Date registered
19/08/2020
Date last updated
27/10/2023
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
A multi-centre assessment of a non-invasive brain pulse oximeter to detect changes in brain oxygen and blood flow in critically ill patients with acute brain injury or 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
The brain pulse oximeter sensors are placed on the forehead or temples along with a conventional skin pulse oximeter. The measurements are undertaken for a minimum of 10 minutes, while the patient remains in the hospital. Hair may need to be shaved in some patients to allow optimal sensor placement.
The protocol does not specify a maximum duration that measurements will be taken
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
Correlation between the brain pulse oximeter oxygen level and 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
Accuracy to detect an episode of CPP < 60 mmHg or < 50 mmHg.

Accuracy will determined using a Bland Altman plot
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
Accuracy of the brain pulse oximeter in comparison to PbtO2 (sub-group of patients where concurrent monitoring is possible).

Accuracy will determined using a Bland Altman plot
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.
Secondary outcome [3] 428224 0
Assess accuracy to detect an episode of brain PbtO2 < 20 mmHg or < 15 mmHg or < 10 mmHg.

Accuracy will determined using a Bland Altman plot
Timepoint [3] 428224 0
At baseline and daily for 4 days
Secondary outcome [4] 428225 0
Strength of relationships between brain pulse oximeter photoplethysmogram changes and routinely collected brain perfusion data including CPP
Timepoint [4] 428225 0
At baseline and daily for 4 days
Secondary outcome [5] 428226 0
Relative changes in oxygen levels and photoplethysmogram changes between ipsilateral and contralateral brain pulse oximeter sensors in relation to routinely collected brain perfusion data including CPP
Timepoint [5] 428226 0
At baseline and daily for 4 days
Secondary outcome [6] 428227 0
Proportion of confirmed secondary brain injuries (in region of brain pulse oximeter) detected by the brain pulse oximeter.
Timepoint [6] 428227 0
At baseline and daily for 4 days
Secondary outcome [7] 428228 0
Time interval between brain pulse oximeter detection of secondary brain injury compared with routine monitoring.

Routine monitoring data will be collected from medical records
Timepoint [7] 428228 0
At baseline and daily for 4 days
Secondary outcome [8] 428229 0
Strength of relationships between brain pulse oximeter photoplethysmogram changes and routinely collected brain perfusion data including ICP
Timepoint [8] 428229 0
At baseline and daily for 4 days
Secondary outcome [9] 428230 0
Strength of relationships between brain pulse oximeter photoplethysmogram changes and routinely collected brain perfusion data including BP
Timepoint [9] 428230 0
At baseline and daily for 4 days
Secondary outcome [10] 428231 0
Strength of relationships between brain pulse oximeter photoplethysmogram changes and routinely collected brain perfusion data including Pbt02
Timepoint [10] 428231 0
At baseline and daily for 4 days
Secondary outcome [11] 428232 0
Relative changes in oxygen levels and photoplethysmogram changes between ipsilateral and contralateral brain pulse oximeter sensors in relation to routinely collected brain perfusion data including CPP
Timepoint [11] 428232 0
At baseline and daily for 4 days
Secondary outcome [12] 428233 0
Relative changes in oxygen levels and photoplethysmogram changes between ipsilateral and contralateral brain pulse oximeter sensors in relation to routinely collected brain perfusion data including ICP
Timepoint [12] 428233 0
At baseline and daily for 4 days
Secondary outcome [13] 428234 0
Relative changes in oxygen levels and photoplethysmogram changes between ipsilateral and contralateral brain pulse oximeter sensors in relation to routinely collected brain perfusion data including BP
Timepoint [13] 428234 0
At baseline and daily for 4 days
Secondary outcome [14] 428235 0
Relative changes in oxygen levels and photoplethysmogram changes between ipsilateral and contralateral brain pulse oximeter sensors in relation to routinely collected brain perfusion data including PbtO2
Timepoint [14] 428235 0
At baseline and daily for 4 days

Eligibility
Key inclusion criteria
Acute brain injury AND/OR

Procedure with risk of brain injury AND/OR

Cardiac or respiratory arrest with presumed hypoxic brain injury

May require mechanical ventilation all of today and tomorrow

May require intra-cranial pressure monitoring AND/OR invasive brain oxygen monitoring

Age >18yrs.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Obtaining brain signal on at least one hemisphere not possible due to a dressing, skin or bone trauma or severely damage brain or haematoma preventing brain pulse detection.

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
Recruiting
Date of first participant enrolment
Anticipated
30/09/2020
Actual
7/10/2020
Date of last participant enrolment
Anticipated
28/10/2024
Actual
Date of last data collection
Anticipated
28/10/2024
Actual
Sample size
Target
100
Accrual to date
102
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17052 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 25596 0
The Alfred - Melbourne
Recruitment hospital [3] 25597 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 25598 0
The Alfred - Melbourne
Recruitment hospital [5] 25599 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [6] 25662 0
The Alfred - Melbourne
Recruitment hospital [7] 25663 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [8] 25690 0
The Alfred - Melbourne
Recruitment hospital [9] 25691 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [10] 25716 0
The Alfred - Melbourne
Recruitment hospital [11] 25717 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [12] 25780 0
The Alfred - Melbourne
Recruitment hospital [13] 25781 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 30723 0
3065 - Fitzroy
Recruitment postcode(s) [2] 41421 0
3004 - Melbourne
Recruitment postcode(s) [3] 41422 0
3050 - Parkville
Recruitment postcode(s) [4] 41423 0
3004 - Melbourne
Recruitment postcode(s) [5] 41424 0
3050 - Parkville
Recruitment postcode(s) [6] 41485 0
3004 - Melbourne
Recruitment postcode(s) [7] 41486 0
3050 - Parkville
Recruitment postcode(s) [8] 41515 0
3004 - Melbourne
Recruitment postcode(s) [9] 41516 0
3050 - Parkville
Recruitment postcode(s) [10] 41540 0
3004 - Melbourne
Recruitment postcode(s) [11] 41541 0
3050 - Parkville
Recruitment postcode(s) [12] 41607 0
3004 - Melbourne
Recruitment postcode(s) [13] 41608 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 305477 0
Commercial sector/Industry
Name [1] 305477 0
Cyban Pty Ltd
Country [1] 305477 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cyban
Address
L18, 1 Nicholson Street, East Melbourne VIC, 3002
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
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
08/09/2020
Ethics approval number [1] 305793 0
63147

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 patients requiring acute neurological monitoring in the hospital or intensive care unit (ICU) with acute brain injury or at high risk of acute neurological deterioration.

It is known that patients with an acute brain injury are at risk of neurological deterioration, typically as a result of low blood flow in the minutes, hours or days after the initial injury. Available brain monitoring is highly invasive and therefore only used in the most severe cases. An accurate non-invasive method to monitor brain oxygen levels and brain blood flow would facilitate monitoring in more patients and earlier detection and treatment of acute neurological deterioration. This could improve healthcare outcomes, reducing both long-term disability and death.

The T-POT pulse oximetry technology can monitor oxygen levels and blood volume changes in organs of the body, including the brain. The sensor and algorithms of the Brain Pulse Oximeter were developed to overcome limitations of conventional pulse oximeters that only provide oxygen and a photoplethysmogram (PPG) signal from blood flow in the skin. The PPG detects blood volume changes in the microvascular bed of a tissue.

The major aim of the study is to assess the correlation of the brain pulse oximeter oxygen levels with invasively measured cerebral perfusion pressure (CPP).
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
Cyban Pty Ltd
L18, 1 Nicholson Street, East Melbourne VIC, 3002
Country 101614 0
Australia
Phone 101614 0
+613439618815
Fax 101614 0
Email 101614 0
[email protected]
Contact person for public queries
Name 101615 0
Dr Barry Dixon
Address 101615 0
Cyban Pty Ltd
L18, 1 Nicholson Street, East Melbourne VIC, 3002
Country 101615 0
Australia
Phone 101615 0
+613439618815
Fax 101615 0
Email 101615 0
[email protected]
Contact person for scientific queries
Name 101616 0
Dr Barry Dixon
Address 101616 0
Cyban Pty Ltd
L18, 1 Nicholson Street, East Melbourne VIC, 3002
Country 101616 0
Australia
Phone 101616 0
+613439618815
Fax 101616 0
Email 101616 0
[email protected]

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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.