Testing Tidal Volume set on ventilator for ventilation therapy
Official title: Study to Investigate an Association Between Brain Activity and Tidal Volume in Humans (BATMAN)
Study to Investigate an Association Between Brain Activity and Tidal Volume in Humans (BATMAN) - a Pilot Study
- 2 groups
- One site, in Toronto
- Recruiting
Interventions
- Medical device
Tidal Volume set on ventilator
Mechanically ventilated patients who are undergoing MRI examinations under general anesthesia in isocapnic and isoxic conditions will have brain activity investigated under two different tidal volumes, 6 ml/kg and 12 ml/kg applied for 3-5 minutes.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario
Eligibility Criteria
See who this study is looking for8 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Patients scheduled to undergo an MRI scan of their head under general anesthesia
- +Age \> 18 years
Exclusion
- −Stroke, and/or brain tumor in the regions of interest that has not been diagnosed before the MRI scan
- −Previous medical history of dementia
- −Acute or chronic spinal cord Injury
- −Previous Vagotomy
- −Phrenic nerve injury
- −Previous medical history of brain surgery
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is investigating how something functions in the body, rather than testing a treatment directly.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Tidal Volume set on ventilator.
Registry label: A: Group 1: tidal volume delivered at 6 ml/kg for 3-5 minutes, followed by 12ml/kg for 3-5 minutes
Group B, the comparison group, receives Tidal Volume set on ventilator.
Registry label: B: Group 2: tidal volume delivered at 12 ml/kg for 3-5 minutes, followed by 6ml/kg for 3-5 minutes
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 10 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: 10 minutes.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
establish a correlation between the tidal volume delivered and changes in the blood-oxygenation level-dependent (BOLD) on regions of interest (ROIs) during an MRI scan — measured over 10 minutes.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06142773 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Tidal Volume set on ventilatorDevice
Mechanically ventilated patients who are undergoing MRI examinations under general anesthesia in isocapnic and isoxic conditions will have brain activity investigated under two different tidal volumes, 6 ml/kg and 12 ml/kg applied for 3-5 minutes.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 10 minutes.
The study as a whole is currently expected to finish around 2026-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 10 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The communication between the lungs and the brain has drawn a lot of attention recently. Animal studies have shown that the breathing cycle is coupled with brain activity, showing that the greater the volume of air delivered to the lungs via a breathing machine greater the brain activity and also the greater the injury to the brain cells. There is no study in humans that investigates the physiological communication between the volume of air delivered to the lungs and brain activity. This is important because really sick patients receive breathing assistance using breathing machines to keep their oxygen levels within a normal range. Although these machines are life-saving tools, they might result in brain cell injury, leading to cognitive impairment. So, establishing the existence of a physiological communication between the volume of air delivered using these breathing machines and brain activity is the first step to investigating therapies to prevent brain cell injury due to the use of breathing machines to assist breathing.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.