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

Ventilation Therapy; Complications Clinical Trial

— BATMAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06142773
• Other study ID #: 23-5052
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University Health Network, Toronto
• Contact: Rongyu ( Cindy) Jin
• Phone: 416-340-4800
• Email: rongyu.jin[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ventilation Therapy; Complications

Intervention

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.

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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