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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ventilation Therapy; Complications
• Intervention / Treatment: Device: Tidal Volume set on ventilator

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rongyu ( Cindy) Jin; Phone Number: 7613 416-340-4800; Email: rongyu.jin@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2N2
      • Recruiting
      • Toronto General Hospital
      • Contact: Rongyu (Cindy) Jin; Phone Number: 7613 416-340-4800; Email: rongyu.jin@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Device: 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.
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	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	10 minutes

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Ewan Goligher, MD, University Health Networ

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 23-5052

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No