The purpose of this study is to calibrate and validate a cerebral oximeter product from Cyban Pty. Ltd. The study will involve comparing cerebral oximeter signals against reference arterial and jugular bulb blood gas measures.

Start Date06 Jan 2025

Sponsor / Collaborator

Cyban Pty Ltd.Startup

NCT06267131 / RecruitingNot Applicable

Transcutaneous Pulse Oximetry Brain Monitoring Study (US): T-POT Study

This is a study of adult patients with a severe and sudden brain injury who have a drain placed in their brain to measure pressure. The purpose of the study is to monitor the pressure in the brain using a monitor placed on the forehead, and compare this to a drain placed in the brain.

Start Date27 Oct 2023

Sponsor / Collaborator

Cyban Pty Ltd.Startup

ISRCTN28562529 / RecruitingNot Applicable

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

Start Date30 Apr 2023

Sponsor / Collaborator

Cyban Pty Ltd.Startup

100 Clinical Results associated with Cyban Pty Ltd.

0 Patents (Medical) associated with Cyban Pty Ltd.

Literatures (Medical) associated with Cyban Pty Ltd.

Medical Devices: Evidence and Research

Assessment of a Non-Invasive Brain Pulse Monitor to Measure Intra-Cranial Pressure Following Acute Brain Injury

Article

Author: Dixon, Barry ; Smith, Paul ; Teo, Elliot J ; Santamaria, John D ; Udy, Andrew ; Sharkey, Jessica M ; Grace, Sally A ; Hellerstedt, Jack ; Savage, Jacqui S

BackgroundIntracranial pressure (ICP) monitoring requires placing a hole in the skull through which an invasive pressure monitor is inserted into the brain. This approach has risks for the patient and is expensive. We have developed a non-invasive brain pulse monitor that uses red light to detect a photoplethysmographic (PPG) signal arising from the blood vessels on the brain's cortical surface. The brain PPG and the invasive ICP waveform share morphological features which may allow measurement of the intracranial pressure.MethodsWe enrolled critically ill patients with an acute brain injury with invasive ICP monitoring to assess the new monitor. A total of 24 simultaneous invasive ICP and brain pulse monitor PPG measurements were undertaken in 12 patients over a range of ICP levels.ResultsThe waveform morphologies were similar for the invasive ICP and brain pulse monitor PPG approach. Both methods demonstrated a progressive increase in the amplitude of P2 relative to P1 with increasing ICP levels. An automated algorithm was developed to assess the PPG morphological features in relation to the ICP level. A correlation was demonstrated between the brain pulse waveform morphology and ICP levels, R²=0.66, P < 0.001.ConclusionThe brain pulse monitor's PPG waveform demonstrated morphological features were similar to the invasive ICP waveform over a range of ICP levels, these features may provide a method to measure ICP levels.Trial RegistrationACTRN12620000828921.

Medical Devices: Evidence and Research

Cerebrovascular Responses in a Patient with Lundberg B Waves Following Subarachnoid Haemorrhage Assessed with a Novel Non-Invasive Brain Pulse Monitor: A Case Report

Author: Jhamb, Ashu ; Dixon, Barry ; Fafiani, Brendan ; Smith, Paul Daniel ; Grace, Sally A ; Petautschnig, Sigrid ; Teo, Elliot John ; Savage, Jacqui S ; Hellerstedt, Jack ; Haydon, Timothy

Subarachnoid haemorrhage (SAH) can trigger a range of poorly understood cerebrovascular responses that may play a role in delayed cerebral ischemia. The brain pulse monitor is a novel non-invasive device that detects a brain photoplethysmography signal that provides information on intracranial pressure (ICP), compliance, blood flow and tissue oxygen saturation. We monitored the cerebrovascular responses in a patient with Lundberg B waves following a SAH. The patient presented with a Fischer grade 4 SAH that required urgent left posterior communicating artery aneurysm coiling and ventricular drain insertion. On hospital day 4 oscillations or spikes on the invasive ICP were noted, consistent with Lundberg B waves. Brain pulse monitoring demonstrated concurrent pulse waveform features consistent with reduced brain compliance and raised ICP over both brain hemispheres. Oxygen levels also demonstrated slow oscillations correlated with the ICP spikes. Brief infrequent episodes of reduced and absent brain pulses were also noted over the right hemisphere. Our findings suggest that the brain pulse monitor holds promise for early detection of delayed cerebral ischemia and could offer insights into the vascular mechanisms at play.

Medical Devices: Evidence and Research

<p>Assessment of a Non-Invasive Brain Oximeter in a Sheep Model of Acute Brain Injury</p>

Article

Author: Turner, Renee ; Christou, Chris ; Dixon, Barry

INTRODUCTIONEvidence suggests treatments guided by brain oxygen levels improve patient outcomes following severe traumatic brain injury; however, brain oxygen levels are not routinely monitored as an effective non-invasive method has not been established. We undertook a study, in a sheep model of acute brain injury, to assess a new non-invasive brain oximeter. The monitor uses the principles of pulse oximetry to record a pulse and oxygen levels.METHODSWe studied 8 sheep. An acute increase in intracranial pressure was induced with an injection of blood into the cranial vault. The temporal changes in the brain oximeter, intracranial pressure and cerebral perfusion pressure were recorded. Simultaneous conventional skin pulse oximetry was also recorded to assess the possible influence of skin blood flow on the brain oximeter signal.RESULTSAt baseline, a pulsatile waveform consistent with the brain circulation was obtained in 7 animals. The baseline brain pulse was quite distinct from the simultaneous conventional skin pulse and similar in shape to a central venous pressure waveform. Injection of blood into the cranial vault triggered an immediate increase in intracranial pressure and fall in cerebral perfusion pressure, by 60-s cerebral perfusion pressure recovered. The brain oximeter oxygen levels demonstrated similar changes with an immediate fall and recovery by 60 s. Periods of high intracranial pressure were also associated with high-frequency oscillations in the brain pulse waveform; there was, however, no change in the conventional skin pulse oximeter pulse waveform.CONCLUSIONThe brain oximeter detected acute changes in both oxygen levels and the brain pulse waveform following an increase in intracranial pressure levels. The brain oximeter could assist clinicians in the management of acute brain injury.

100 Deals associated with Cyban Pty Ltd.

100 Translational Medicine associated with Cyban Pty Ltd.

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