Study to Investigate an Association Between Brain Activity and Tidal Volume in Humans (BATMAN)
- Conditions
- Ventilation Therapy; Complications
- Interventions
- Device: Tidal Volume set on ventilator
- Registration Number
- NCT06142773
- Lead Sponsor
- University Health Network, Toronto
- Brief Summary
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.
- Detailed Description
Demonstration of a physiological relationship between tidal volume set on the ventilator and hippocampal activity measured as changes in blood-oxygenation level-dependent (BOLD) in the regions of interest (ROIs). The results from this pilot study might assist in creating the foundation for explaining the mechanism of action of ventilation-associated brain injury.
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. Positive end-expiratory pressure will be adjusted to maintain plateau pressure \<30 cm H2O.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- Patients scheduled to undergo an MRI scan of their head under general anesthesia
- Age > 18 years
- 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
- Previous Vagotomy
- Phrenic nerve injury
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group 1: tidal volume delivered at 6 ml/kg for 3-5 minutes, followed by 12ml/kg for 3-5 minutes Tidal Volume set on ventilator The clinical MRI examination will be obtained before commencing with the study protocol. The study protocol will commence once the scheduled MRI scan is finished. The study-related procedures will add 10 minutes after the scheduled MRI scans are finished with two different tidal volumes with maintaining isocapnia and isooxia. Study procedure: tidal volume delivered at 6 ml/kg for 5 minutes, followed by 12ml/kg for 5 minutes Group 2: tidal volume delivered at 12 ml/kg for 3-5 minutes, followed by 6ml/kg for 3-5 minutes Tidal Volume set on ventilator The clinical MRI examination will be obtained before commencing with the study protocol. The study protocol will commence once the scheduled MRI scan is finished. The study-related procedures will add 10 minutes after the scheduled MRI scans are finished with two different tidal volumes with maintaining isocapnia and isooxia. Study procedure: tidal volume delivered at 12 ml/kg for 5 minutes, followed by 6ml/kg for 5 minutes
- Primary Outcome Measures
Name Time Method 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. 10 minutes correlation between the tidal volume delivered and changes in the blood-oxygenation level-dependent (BOLD) on regions of interest (ROIs)
- Secondary Outcome Measures
Name Time Method establish whether the changes in BOLD signal in multiple ROIs correlate with changes in tidal volume via a multi-correlation analysis (independent component analysis) 10 minutes establish whether the changes in BOLD signal in multiple ROIs correlate with changes in tidal volume via a multi-correlation analysis
Trial Locations
- Locations (1)
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada