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Transcutaneous Pulse Oximetry Brain Monitoring Study

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000828921
Acronym
T-POT Study
Enrollment
102
Registered
2020-08-19
Start date
2020-10-07
Completion date
2024-10-28
Last updated
2023-11-06

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

Conditions

None listed

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).

Interventions

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

Sponsors

Cyban
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 10, 2026