Clinical trial NCT06267131: Transcutaneous Pulse Oximetry Brain Monitoring Study (US)
Official title: Transcutaneous Pulse Oximetry Brain Monitoring Study (US): T-POT Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Brain Injury
Lead sponsor: Cyban Pty Ltd
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single center prospective observational cohort study
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Agreement of the brain oximeter levels compared with invasive ICP levels
timeFrame: Daily recordings for up to 30 days while the patient has an invasive ICP probe in situ
Secondary outcomes:
measure: Optical signal changes associated with periods of brain hypoxia and surrogate ICP waveform
timeFrame: Daily recordings for up to 30 days while the patient has an invasive ICP probe in situ
measure: Optical signal changes associated with non-convulsive seizures via EEG monitoring (Alpha, Beta, Theta)
timeFrame: Daily recordings for up to 30 days while the patient has an invasive ICP probe in situ
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, Neurological Institute
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Catherine Hassett, DO
role: PRINCIPAL_INVESTIGATOR
References: