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.
The device is a non-invasive brain pulse oximeter. It uses red and near-infrared light and provides a signal which represents the change in blood volume associated with each heartbeat. The brain signal allows a number of clinically important end-points to be determined, including brain blood flow, oxygen and pressure levels. The T-Pot (US) Study will be undertaken in patients that require invasive brain monitoring. The primary aim of the study is to assess the accuracy of the brain pulse oximeter compared with the traditional invasive intracranial pressure (ICP) monitoring.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
15
Sensor is placed on the right and/or left forehead and maintained with an elasticized headband. The duration of monitoring will last for approximately 60 minutes per monitoring session to obtain sufficient data. Serial monitoring will occur on three consecutive days.
Cleveland Clinic, Neurological Institute
Cleveland, Ohio, United States
RECRUITINGAgreement of the brain oximeter levels compared with invasive ICP levels
Correlation of the optical signal waveforms with the invasive ICP waveforms and level
Time frame: Daily recordings for up to 30 days while the patient has an invasive ICP probe in situ
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
Time frame: Daily recordings for up to 30 days while the patient has an invasive ICP probe in situ
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)
Time frame: Daily recordings for up to 30 days while the patient has an invasive ICP probe in situ
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