Acute Brain InjuryT-POT USNCT06267131
Transcutaneous Pulse Oximetry Brain Monitoring Study (US)
A study testing Brain Pulse Oximeter in people with Acute Brain Injury, run by Cyban Pty Ltd at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Brain Injury
- What is being tested?
- Brain Pulse Oximeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2023to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic, Neurological Institute
Cleveland, Ohio, 44195
Catherine Hassett, DO, 216-445-1385, HASSETC@ccf.org
Joao Gomes, MD, 216-445-1385, GOMESJ@ccf.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Brain Injury
- Being tested
- Brain Pulse Oximeter
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Pulse OximeterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Enrolled patients | Other | All enrolled patients will have brain pulse monitoring Receives: Device: Brain Pulse Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of the brain oximeter levels compared with invasive ICP levels
Correlation of the optical signal waveforms with the invasive ICP waveforms and level
Measured: 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
Correlation of optical signal waveforms with clinical or other evidence of hypoxia
Measured: 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)
Measured: Daily recordings for up to 30 days while the patient has an invasive ICP probe in situ
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start27 Oct 2023
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single center prospective observational cohort study
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cyban Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catherine Hassett, DO, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267131
- Sponsor's protocol ID
- IRB 22-1286
- Acronym
- T-POT US
- Status last verified
- Feb 2024
- First submitted
- 8 Nov 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Pulse Oximetry Brain Monitoring Study (US): T-POT Study
- ClinicalTrials.gov ID
- NCT06267131
- Acronym / sponsor ID
- T-POT US / IRB 22-1286
- Conditions
- Acute Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cyban Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center prospective observational cohort study
| Arm | Type | Receives |
|---|---|---|
| Enrolled patients | Other | Device: Brain Pulse OximeterAll enrolled patients will have brain pulse monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Pulse OximeterSensor 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. | Device | Enrolled patients |
Primary outcome
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
Correlation of the optical signal waveforms with the invasive ICP waveforms and level
2 secondary outcomes
Optical signal changes associated with periods of brain hypoxia and surrogate ICP waveform
Time frame: 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)
Time frame: Daily recordings for up to 30 days while the patient has an invasive ICP probe in situ
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Hassett, DO principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Pulse Oximeter in people with Acute Brain Injury, run by Cyban Pty Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine Hassett, DO (866.320.4573, HASSETC@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.