Investigating the link between brain activity and breathing volume in humans
Study to Investigate an Association Between Brain Activity and Tidal Volume in Humans (BATMAN) - a Pilot Study
This study is testing how different amounts of air from a ventilator affect brain activity in critically ill patients to see if it could help prevent brain injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06142773 on ClinicalTrials.gov |
What this trial studies
This study explores the relationship between the volume of air delivered to the lungs by a ventilator and brain activity in humans. It aims to establish whether changes in tidal volume affect brain activity, particularly in the hippocampus, using MRI scans during general anesthesia. By comparing brain activity at two different tidal volumes, the study seeks to understand the potential for ventilation-associated brain injury in critically ill patients. The findings could pave the way for therapies to mitigate cognitive impairment linked to mechanical ventilation.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are scheduled for an MRI scan of the head under general anesthesia.
Not a fit: Patients with a history of stroke, brain tumors, dementia, or significant neurological injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved ventilation strategies that minimize brain injury and cognitive impairment in critically ill patients.
How similar studies have performed: While animal studies have shown a connection between breathing volume and brain activity, this is the first investigation of its kind in humans, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients scheduled to undergo an MRI scan of their head under general anesthesia 2. Age \> 18 years Exclusion Criteria: 1. Stroke, and/or brain tumor in the regions of interest that has not been diagnosed before the MRI scan 2. Previous medical history of dementia 3. Previous medical history of brain surgery 4. Acute or chronic spinal cord Injury 5. Previous Vagotomy 6. Phrenic nerve injury
Where this trial is running
Toronto, Ontario
- Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Ewan Goligher, MD — University Health Networ
- Study coordinator: Rongyu ( Cindy) Jin
- Email: rongyu.jin@uhn.ca
- Phone: 416-340-4800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.