T-POT
Research type
Research Study
Full title
Transcutaneous Pulse Oximetry Brain Monitoring Study (UK)
IRAS ID
313977
Contact name
Johnathan Rhodes
Contact email
Sponsor organisation
Cyban Pty ltd
Clinicaltrials.gov Identifier
Australian New Zealand Clinical Trials Registry, ACTRN12620000828921p
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Summary of Research
A non invasive brain pulse oximeter has been developed to monitor blood oxygen levels in the brain. The technology uses near infrared light and provides a continuous pulsatile signal or photoplethysmogram (PPG) which represents the change in blood volume in the brain due to each pulse of blood.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 the traditional invasive oxygen monitoring.
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.
Human studies including in the ICU setting, in Australia, have already been undertaken and demonstrated the brain pulse oximeter is safe and effective.
Summary of Results
The study was intended to compare invasive brain oxygen measurements with a non invasive surrogate. Two patients were enrolled in the study. For one patient we received invasive brain oxygen measurements with no non-invasive data. The second patient we received no brain oxygen data. No paired data was gleaned from this study.REC name
Scotland A: Adults with Incapacity only
REC reference
22/SS/0041
Date of REC Opinion
9 Aug 2022
REC opinion
Further Information Favourable Opinion