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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Brain Injury
• Intervention / Treatment: Device: Brain Pulse Oximeter

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine Hassett, DO; Phone Number: 866.320.4573; Email: HASSETC@ccf.org
• Study Contact Backup: Name: Joao Gomes; Phone Number: 866.320.4573.; Email: GOMESJ@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic, Neurological Institute
      • Contact: Catherine Hassett, DO; Phone Number: 216-445-1385; Email: HASSETC@ccf.org
      • Contact: Joao Gomes, MD; Phone Number: 216-445-1385; Email: GOMESJ@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Enrolled patients; All enrolled patients will have brain pulse monitoring	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optical signal changes associated with periods of brain hypoxia and surrogate ICP waveform	Correlation of optical signal waveforms with clinical or other evidence of hypoxia	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)	Correlation of optical signal waveforms with EEG monitoring (Alpha, Beta, Theta)	Daily recordings for up to 30 days while the patient has an invasive ICP probe in situ

Collaborators and Investigators

• Sponsor: Cyban Pty Ltd
• Investigators: Principal Investigator: Catherine Hassett, DO, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: February 18, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: IRB 22-1286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No