RECRUITING

Transcutaneous Pulse Oximetry Brain Monitoring Study (US)

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Conditions

Acute Brain Injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-10-27
Study Completion:2024-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06267131

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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. * 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. * 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. * 2. Hemodynamically unstable patients (defined as increasing vasopressors requirements)
  3. * 3. Patients with unstable mechanical ventilation support defined as increasing fractional inspired oxygen (FiO2) requirements

Contacts and Locations

Study Contact

Catherine Hassett, DO
CONTACT
866.320.4573
HASSETC@ccf.org
Joao Gomes
CONTACT
866.320.4573.
GOMESJ@ccf.org

Principal Investigator

Catherine Hassett, DO
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Cyban Pty Ltd

  • Catherine Hassett, DO, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-27
Study Completion Date2024-11

Study Record Updates

Study Start Date2023-10-27
Study Completion Date2024-11

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Brain Injury