Study to Investigate an Association Between Brain Activity and Tidal Volume in Humans (BATMAN)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients scheduled to undergo an MRI scan of their head under general anesthesia

Age > 18 years

Disqualifiers

Stroke, and/or brain tumor in the regions of interest that has not been diagnosed before the MRI scan

Previous medical history of dementia

Previous medical history of brain surgery

Acute or chronic spinal cord Injury

Trial design

Design model

Crossover

Treatments tested in this trial

  • Tidal Volume set on ventilator

    Device

    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.

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Group 1: tidal volume delivered at 6 ml/kg for 3-5 minutes, followed by 12ml/kg for 3-5 minutesExperimental treatment 1 intervention
Group B: Group 2: tidal volume delivered at 12 ml/kg for 3-5 minutes, followed by 6ml/kg for 3-5 minutesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

correlation between the tidal volume delivered and changes in the blood-oxygenation level-dependent (BOLD) on regions of interest (ROIs)

Time frame
10 minutes

Secondary outcomes

1

establish whether the changes in BOLD signal in multiple ROIs correlate with changes in tidal volume via a multi-correlation analysis (independent component analysis)

establish whether the changes in BOLD signal in multiple ROIs correlate with changes in tidal volume via a multi-correlation analysis

Time frame
10 minutes

Other outcomes

Sponsors and contacts

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