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Ventilator Settings for Ventilation Therapy Complications (BATMAN Trial)

N/A

Recruiting

Led By Ewan Goligher, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years

Patients scheduled to undergo an MRI scan of their head under general anesthesia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 minutes

Awards & highlights

BATMAN Trial Summary

This trial studies the connection between lungs & brain activity: how the volume of air delivered to the lungs via a machine affects brain activity & injury.

Who is the study for?

This trial is for adults over 18 who are already scheduled for an MRI scan of their head under general anesthesia. It's not suitable for those with undiagnosed stroke or brain tumors in certain areas, a history of dementia or brain surgery, spinal cord injury, previous vagotomy, or phrenic nerve injury.Check my eligibility

What is being tested?

The BATMAN study is looking at how different volumes of air delivered by a ventilator (tidal volume) affect brain activity in humans. The goal is to understand if the amount of air given can influence both brain function and potential damage to brain cells.See study design

What are the potential side effects?

Since this study observes existing treatment rather than testing new drugs, side effects relate mainly to standard risks associated with ventilation therapy such as lung tissue damage and cognitive issues post-treatment.

BATMAN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I am scheduled for a head MRI under general anesthesia.

BATMAN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

Secondary outcome measures

establish whether the changes in BOLD signal in multiple ROIs correlate with changes in tidal volume via a multi-correlation analysis (independent component analysis)

BATMAN Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 1: tidal volume delivered at 6 ml/kg for 3-5 minutes, followed by 12ml/kg for 3-5 minutesExperimental Treatment1 Intervention

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

Group II: Group 2: tidal volume delivered at 12 ml/kg for 3-5 minutes, followed by 6ml/kg for 3-5 minutesActive Control1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

485,170 Total Patients Enrolled

Ewan Goligher, MDPrincipal InvestigatorUniversity Health Networ

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for this scientific investigation?

"The information on clinicaltrials.gov confirms that this study is no longer recruiting patients; the original posting was made on November 30th 2023 and the last edit also occured in November of 2023. However, there are 10 other trials currently open for patient recruitment at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study to Investigate an Association Between Brain Activity and Tidal Volume in Humans (BATMAN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06142773.