Transcutaneous Pulse Oximetry Brain Monitoring Study (US)

NCT06267131 | Recruiting

• 1 other identifier: IRB 22-1286
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Agreement of the brain oximeter levels compared with invasive ICP levels

  Correlation of the optical signal waveforms with the invasive ICP waveforms and level

  Daily recordings for up to 30 days while the patient has an invasive ICP probe in situ

Secondary Outcomes (2)

• 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

• 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

Study Arms (1)

Enrolled patients

OTHER

All enrolled patients will have brain pulse monitoring

Device: Brain Pulse Oximeter

Interventions

Brain Pulse Oximeter DEVICE

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.

Enrolled patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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
• \. 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

You may not qualify if:

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

Sponsors & Collaborators

• Cyban Pty Ltd: lead

Study Sites (1)

Cleveland Clinic, Neurological Institute

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Catherine Hassett, DO

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Hassett, DO

CONTACT

866.320.4573; HASSETC@ccf.org

Joao Gomes

CONTACT

866.320.4573.; GOMESJ@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single center prospective observational cohort study

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: February 20, 2024
• Study Start: October 27, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)