Actively Recruiting
Study to Investigate an Association Between Brain Activity and Tidal Volume in Humans (BATMAN) - a Pilot Study
Led by University Health Network, Toronto · Updated on 2025-03-06
10
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the connection between lung ventilation and brain activity, focusing on how the volume of air delivered by breathing machines may affect the brain. Animal studies suggest that higher volumes of air given through ventilators can increase brain activity but also cause brain cell injury. This study aims to understand this relationship in humans, especially in very sick patients who need breathing machines to maintain oxygen levels but may risk cognitive problems due to brain injury. The study involves mechanically ventilated patients undergoing MRI scans under general anesthesia with stable carbon dioxide and oxygen levels. Brain activity will be measured using MRI blood-oxygenation signals while applying two different tidal volumes: 6 ml/kg and 12 ml/kg, each for 3 to 5 minutes. Positive end-expiratory pressure will be adjusted to keep lung pressure below 30 cm H2O. Two groups will receive the tidal volumes in opposite sequences to compare effects. Participants will have their routine MRI brain scan followed by an additional 10 minutes of study-specific ventilation at the two tidal volumes during MRI. Researchers will measure changes in brain activity in specific regions of interest and analyze correlations with tidal volume changes. This study will help understand ventilation-associated brain injury mechanisms by monitoring brain signals during controlled breathing support.
CONDITIONS
Brief Title
Study to Investigate an Association Between Brain Activity and Tidal Volume in Humans (BATMAN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled to undergo an MRI scan of their head under general anesthesia
- Age greater than 18 years
You will not qualify if you...
- Stroke or brain tumor in the regions of interest not 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 10 minutes
Participants undergo scheduled clinical MRI scans under general anesthesia. After the clinical scan, the study protocol involves applying two different tidal volumes on the ventilator for 3-5 minutes each while brain activity is measured during MRI.
1 visit during scheduled MRI examination
Trial Site Locations
Total: 1 location
1
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Actively Recruiting
Research Team
R
Rongyu ( Cindy) Jin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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