Transcutaneous pulse oximetry brain monitoring study
| ISRCTN | ISRCTN28562529 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28562529 |
| IRAS number | 313977 |
| Secondary identifying numbers | IRAS 313977, CPMS 52215 |
- Submission date
- 27/04/2023
- Registration date
- 09/05/2023
- Last edited
- 05/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Acute brain injury is a major public health burden globally and is the leading cause of death and long-term disability among young people. Evidence indicates that early detection of hypoxia (low oxygen in your tissues) and early treatment to prevent brain injury improved patient outcomes. A non-invasive (outside the body) monitoring device has been developed to monitor blood oxygen levels in the brain. The study will compare the new monitoring device with traditional invasive (inside the body) oxygen monitoring.
Who can participate?
Patients with a brain injury requiring invasive brain oxygen monitoring
What does the study involve?
The study involves placing a sensor on either side of the forehead, along with a conventional skin pulse monitor. A small patch of hair may need to be shaved in some patients to allow optimal sensor placement. Sensors will be left in place for approximately 30 minutes. Multiple episodes of monitoring may occur on a given day. Other routinely measured data such as heart rate, respiratory rate and blood pressure will be captured where possible.
What are the possible benefits and risks of participating?
There is no direct benefit from participating in this research. The knowledge gained from this research may be beneficial for other patients, society or science.
Where is the study run from?
NHS Lothian, Edinburgh (UK)
When is the study starting and how long is it expected to run for?
February 2022 to June 2024
Who is funding the study?
Cyban Pty Ltd (Australia)
Who is the main contact?
Dr Barry Dixon, barry.dixon@cyban.com.au
Contact information
Principal Investigator
ICU, Ward 118, Royal Infirmary of Edinburgh
Little France Crescent
Edinburgh
EH16 4SB
United Kingdom
| Phone | +44 (0)131 242 1186 |
|---|---|
| jrhodes1@exseed.ed.ac.uk |
Scientific
L18
1 Nicholson Street
East Melbourne VIC
3002
Australia
| Phone | +613439618815 |
|---|---|
| barry.dixon@cyban.com.au |
Public
L18
1 Nicholson Street
East Melbourne VIC
3002
Australia
| Phone | +61458750078 |
|---|---|
| david.mitchell@cyban.com.au |
Study information
| Study design | Prospective data collection non-randomized single-center study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | No participant information sheet available |
| Scientific title | The T-POT study will be undertaken in patients with a brain injury requiring invasive brain oxygen monitoring. The study will assess the accuracy of a new non-invasive brain pulse oximeter compared with traditional invasive oxygen monitoring |
| Study acronym | T-POT (UK) |
| Study objectives | The development of an accurate non-invasive method to measure brain oxygen levels could lead to major improvements in patient outcomes through earlier detection and treatment of brain hypoxia, a major cause of secondary brain injury. This simpler, safer, approach would allow monitoring to be part of the routine care of all patients at risk, not just high-risk patients. |
| Ethics approval(s) | Approved 09/08/2022, Scotland A Research Ethics Committee (Research Ethics Service, 2nd Floor Waverley Gate, 2-4 Waterloo Place, Edinburgh, EH1 3EG, UK; +44(0)131 465 5680; ruth.fraser4@nhslothian.scot.nhs.uk), ref: 22/SS/0041 |
| Health condition(s) or problem(s) studied | Patients with a brain injury requiring invasive brain oxygen |
| Intervention | One brain pulse oximeter sensor is placed on each hemisphere, along with a conventional skin pulse oximeter. A small path of hair may need to be shaved in some patients to allow optimal sensor placement. The brain pulse oximeter sensors typically only need to be left on for a period of 30 minutes. Multiple episodes of monitoring may occur on a given day to allow the capture of changes in the partial pressure of oxygen in brain tissue (PbtO2) levels. The study period will end once the invasive brain oxygen level has been removed and there is no prospect it will recur. Placement of the brain pulse oximeter sensors and data collection will be undertaken by the trained trial researchers. In addition to PbtO2, other routinely measured ICU physiological data including intracranial pressure, central venous pressure, heart rate, respiration rate and blood pressure will be captured automatically, where possible. Also, information from routine investigational data, such as (CT, MRI, cerebral angiogram, EEG, sensory evoked potentials, doppler US), admission and operative notes will be captured in the case report form to document the timing, size and nature of the brain injury and any complications (for example intracranial bleed, cerebral ischaemia/infarction, hydrocephalus, cerebral oedema or vasospasm) over the study period. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Brain Pulse Oximeter (BPox) |
| Primary outcome measure | Brain oxygen levels measured using both the brain pulse oximeter and conventional skin pulse oximeter during the study |
| Secondary outcome measures | Brain oxygen levels where PbtO2 < 20 mmHg or < 15 mmHg measured using both the brain pulse oximeter and conventional skin pulse oximeter to assess the accuracy to detect an episode during the study |
| Overall study start date | 11/02/2022 |
| Completion date | 30/08/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 15 |
| Key inclusion criteria | Patients with invasive brain oxygen monitoring as part of their routine care |
| Key exclusion criteria | 1. Brain pulse oximeter signal cannot be obtained from at least one brain hemisphere due to an interference issue such as head dressing, severe skin or bone trauma or skull removal preventing brain pulse detection 2. Invasive PbtO2 monitor output believed to be inaccurate by ICU clinicians due to technical limitations with the device |
| Date of first enrolment | 30/04/2023 |
| Date of final enrolment | 30/06/2024 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
Sponsor information
Industry
L18, 1 Nicholson Street
East Melbourne, VIC
3002
Australia
| Phone | +613439618815 |
|---|---|
| barry.dixon@cyban.com.au | |
| Website | https://www.cyban.com.au/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The pooled results of the trial will be published in an open-access peer-reviewed scientific journal. The results will also be presented to peers at a national or international scientific conference. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
05/06/2023: Internal review.
