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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06267131
Other study ID # IRB 22-1286
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 27, 2023
Est. completion date November 2024

Study information

Verified date February 2024
Source Cyban Pty Ltd
Contact Catherine Hassett, DO
Phone 866.320.4573
Email HASSETC@ccf.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Brain 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.

Locations

Country Name City State
United States Cleveland Clinic, Neurological Institute Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
Cyban Pty Ltd

Country where clinical trial is conducted

United States, 

Outcome

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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