Recruiting

Oximetry Monitoring

Sponsor:

Cyban Pty Ltd

Code:

NCT06267131

Conditions

Acute Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brain Pulse Oximeter

Study Details

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.

Conditions

Acute Brain Injury

Study ID

NCT06267131

Start date

Oct 27, 2023

Status verified date

Feb, 2024

Completion date

Nov, 2024

Anticipated

Primary completion date

Nov, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Enrolled patients

All enrolled patients will have brain pulse monitoring

Interventions

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.

Primary outcome measure

  • Agreement of the brain oximeter levels compared with invasive ICP levels [ Time Frame: Daily recordings for up to 30 days while the patient has an invasive ICP probe in situ ]

Central Contacts and Locations

Central contacts

Catherine Hassett, DO

866.320.4573HASSETC@ccf.org

Joao Gomes

866.320.4573.GOMESJ@ccf.org

Locations

Cleveland Clinic, Neurological Institute

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Catherine Hassett, DO

216-445-1385HASSETC@ccf.org

Joao Gomes, MD

216-445-1385GOMESJ@ccf.org

More Information

Sponsor

Cyban Pty Ltd

Last update posted

Feb 20, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cyban Pty Ltd on 2024-02-20.