Monitoring brain pressure using a non-invasive device
Transcutaneous Pulse Oximetry Brain Monitoring Study (US): T-POT Study
This study is testing a new non-invasive device that uses light to measure brain pressure in adults with severe brain injuries to see if it works as well as traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cyban Pty Ltd Industry-sponsored |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06267131 on ClinicalTrials.gov |
What this trial studies
This study focuses on adult patients with severe acute brain injuries who have an external ventricular drain for monitoring intracranial pressure. It aims to evaluate the accuracy of a non-invasive brain pulse oximeter placed on the forehead in comparison to traditional invasive methods. The device utilizes red and near-infrared light to measure changes in blood volume, providing critical information about brain blood flow, oxygen levels, and pressure. The study will assess the effectiveness of this monitoring technique in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are adult patients with severe brain injuries requiring invasive intracranial pressure monitoring.
Not a fit: Patients who are hemodynamically unstable or unable to obtain a signal from the brain pulse oximeter will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a safer and more effective method for monitoring brain pressure in patients with acute brain injuries.
How similar studies have performed: While similar non-invasive monitoring approaches have been explored, this specific method is novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. Adult brain-injured patients who have undergone external ventricular drain insertion for cerebrospinal fluid drainage and invasive intracranial pressure monitoring as part of standard medical care * 2. Adult brain-injured patients who have undergone external ventricular drain insertion for cerebrospinal fluid drainage and invasive intracranial pressure monitoring that have concomitant continuous electroencephalography (EEG) monitoring as part of standard medical care Exclusion Criteria: * 1. Inability to obtain the brain pulse oximeter signal from at least one brain hemisphere due to interface issue such as severe agitation, head dressing, severe skin or bone trauma, or skull removal preventing brain pulse detection for the initial monitoring session. a. Note: If unable to obtain brain pulse oximeter signal for subsequent monitoring sessions, the only the recordings that were obtained will be used for analysis * 2. Hemodynamically unstable patients (defined as increasing vasopressors requirements) * 3. Patients with unstable mechanical ventilation support defined as increasing fractional inspired oxygen (FiO2) requirements
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic, Neurological Institute — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Catherine Hassett, DO — The Cleveland Clinic
- Study coordinator: Catherine Hassett, DO
- Email: HASSETC@ccf.org
- Phone: 866.320.4573
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.