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Transcutaneous pulse oximetry brain monitoring study

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN28562529
Enrollment
15
Registered
2023-05-09
Start date
2023-04-30
Completion date
Unknown
Last updated
2023-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with a brain injury requiring invasive brain oxygen Injury, Occupational Diseases, Poisoning

Interventions

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 placeme

Sponsors

Cyban Pty Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with invasive brain oxygen monitoring as part of their routine care

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Brain oxygen levels measured using both the brain pulse oximeter and conventional skin pulse oximeter during the study

Secondary

MeasureTime frame
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

Countries

Scotland, United Kingdom

Contacts

Public ContactDavid Mitchell
david.mitchell@cyban.com.au+61458750078

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026