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

NCT06142773 | Recruiting

• 1 other identifier: 23-5052
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

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

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

Interventions

Tidal Volume set on ventilator DEVICE

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.

Group 1: tidal volume delivered at 6 ml/kg for 3-5 minutes, followed by 12ml/kg for 3-5 minutes; Group 2: tidal volume delivered at 12 ml/kg for 3-5 minutes, followed by 6ml/kg for 3-5 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo an MRI scan of their head under general anesthesia
• Age \> 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

Study Officials

• Ewan Goligher, MD

  University Health Networ

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rongyu ( Cindy) Jin

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 21, 2023
• Study Start: November 30, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 6, 2025

Record last verified: 2025-01

Locations

CA (1)