Recruiting

BATMAN

Sponsor:

University Health Network, Toronto

Code:

NCT06142773

Conditions

Ventilation Therapy; Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tidal Volume set on ventilator

Study Details

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.

Conditions

Ventilation Therapy; Complications

Study ID

NCT06142773

Start date

Nov 30, 2023

Status verified date

Jan, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Group 1: tidal volume delivered at 6 ml/kg for 3-5 minutes, followed by 12ml/kg for 3-5 minutes

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

active comparator: Group 2: tidal volume delivered at 12 ml/kg for 3-5 minutes, followed by 6ml/kg for 3-5 minutes

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

Interventions

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.

Primary outcome measure

  • 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. [ Time Frame: 10 minutes ]

Central Contacts and Locations

Central contacts

Rongyu ( Cindy) Jin

416-340-4800rongyu.jin@uhn.ca

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contacts

Rongyu (Cindy) Jin

416-340-4800rongyu.jin@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 6, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-03-06.