Transcutaneous Pulse Oximetry Brain Monitoring Study (US)

Not Applicable

Recruiting

• Conditions: Acute Brain Injury
• Interventions: Device: Brain Pulse Oximeter

• Registration Number: NCT06267131
• Lead Sponsor: Cyban Pty Ltd

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.

Study Timeline

• Study Start: 2023-10-27
• Study First Submitted: 2023-11-08
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-18
• Last Update Submitted: 2024-02-18
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enrolled patients	Brain Pulse Oximeter	All enrolled patients will have brain pulse monitoring

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Cleveland Clinic, Neurological Institute; 🇺🇸 Cleveland, Ohio, United States