Transcutaneous Pulse Oximetry Brain Monitoring Study (US)

Description

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.

Conditions

Acute Brain Injury

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Study Overview

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Study Details

Study overview

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.

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

Transcutaneous Pulse Oximetry Brain Monitoring Study (US)

Condition
Acute Brain Injury
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic, Neurological Institute, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.
  • * 2. Hemodynamically unstable patients (defined as increasing vasopressors requirements)
  • * 3. Patients with unstable mechanical ventilation support defined as increasing fractional inspired oxygen (FiO2) requirements

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cyban Pty Ltd,

Catherine Hassett, DO, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2024-11