Transcutaneous Pulse Oximetry Brain Monitoring Study (US)

Acute Brain Injury Clinical Trial

— T-POT US  

Official title:

Transcutaneous Pulse Oximetry Brain Monitoring Study (US): T-POT Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06267131
• Other study ID #: IRB 22-1286
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Acute Brain Injury
• Brain Injuries

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