Acute Brain Injury
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBrain Pulse Oximeter
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.
Sponsors
Cyban Pty Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Single center prospective observational cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement of the brain oximeter levels compared with invasive ICP levels | Daily recordings for up to 30 days while the patient has an invasive ICP probe in situ | Correlation of the optical signal waveforms with the invasive ICP waveforms and level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Optical signal changes associated with periods of brain hypoxia and surrogate ICP waveform | Daily recordings for up to 30 days while the patient has an invasive ICP probe in situ | Correlation of optical signal waveforms with clinical or other evidence of hypoxia |
| Optical signal changes associated with non-convulsive seizures via EEG monitoring (Alpha, Beta, Theta) | Daily recordings for up to 30 days while the patient has an invasive ICP probe in situ | Correlation of optical signal waveforms with EEG monitoring (Alpha, Beta, Theta) |
Countries
United States
Contacts
Primary ContactCatherine Hassett, DO
Backup ContactJoao Gomes
Outcome results
None listed