Acute Brain Injury Clinical Trial
— T-POT USOfficial title:
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | November 2024 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic, Neurological Institute | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Cyban Pty Ltd |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Agreement of the brain oximeter levels compared with invasive ICP levels | Correlation of the optical signal waveforms with the invasive ICP waveforms and level | Daily recordings for up to 30 days while the patient has an invasive ICP probe in situ | |
Secondary | Optical signal changes associated with periods of brain hypoxia and surrogate ICP waveform | Correlation of optical signal waveforms with clinical or other evidence of hypoxia | Daily recordings for up to 30 days while the patient has an invasive ICP probe in situ | |
Secondary | Optical signal changes associated with non-convulsive seizures via EEG monitoring (Alpha, Beta, Theta) | Correlation of optical signal waveforms with EEG monitoring (Alpha, Beta, Theta) | Daily recordings for up to 30 days while the patient has an invasive ICP probe in situ |
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