Ventilator Settings for Ventilation Therapy Complications

(BATMAN Trial)

Overseen By Rongyu ( Cindy) Jin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Stroke, Brain tumor, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how breathing machines, which assist patients in breathing, might affect brain activity. Researchers aim to determine if the air volume delivered by these machines (tidal volume set on the ventilator) can cause brain cell injury. By testing different air volumes, they seek safer ways to use these machines without harming the brain. This trial may suit patients already scheduled for an MRI of their head under general anesthesia and without a history of brain conditions like dementia or tumors. As an unphased trial, it offers patients the chance to contribute to important research that could enhance the safety of breathing machines for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these ventilator settings are safe for ventilation therapy?

Research shows that adjusting the settings on breathing machines, such as the tidal volume, can impact patient safety. Studies have found that using lower tidal volumes reduces the risk of lung problems in patients without acute respiratory distress syndrome (ARDS).

Setting the tidal volume too high might cause the lungs to overinflate, leading to harmful effects like barotrauma, a lung injury from excessive pressure. Conversely, maintaining low tidal volumes appears to lower these risks and generally benefits lung health.

In this trial, researchers are testing two different tidal volume settings to assess their effects on the brain and lungs. These settings are carefully chosen to provide sufficient oxygen while minimizing potential harm. Although no direct human studies have examined how these settings affect the brain, they are based on principles known to reduce lung injury. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different ventilator settings can impact complications in ventilation therapy. Unlike the standard practice, which typically uses a consistent tidal volume setting, this trial investigates alternating tidal volumes to see if it can better maintain isocapnia (stable CO2 levels) and isooxia (stable oxygen levels). By switching between lower and higher tidal volumes, the trial aims to uncover whether this approach can reduce the risk of complications, potentially leading to more tailored and effective ventilation strategies for patients.

What evidence suggests that these ventilator settings could be effective for preventing brain cell injury?

This trial will compare different tidal volumes set on ventilators to assess their impact on brain and lung health. Research has shown that the amount of air provided by breathing machines, known as tidal volume, can affect brain activity. Animal studies found that increasing the air can boost brain activity but might also harm brain cells. Using a low amount of air helps protect the lungs during mechanical breathing. However, too much air can damage the lungs, so finding the right balance is important. These findings suggest that adjusting the air volume might help prevent injuries to the brain and lungs during breathing therapy. Participants in this trial will be assigned to receive either a tidal volume of 6 ml/kg followed by 12 ml/kg, or the reverse sequence, to evaluate these effects. ^{6 7 8 9 10}

Who Is on the Research Team?

Ewan Goligher, MD

Principal Investigator

University Health Networ

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am older than 18 years.

I am scheduled for a head MRI under general anesthesia.

Exclusion Criteria

I have an undiagnosed stroke or brain tumor in the area of interest.

I have a spinal cord injury.

I have had brain surgery in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

MRI Examination

Participants undergo a clinical MRI examination before the study protocol begins

Varies

1 visit (in-person)

Study Protocol

Participants receive tidal volume interventions during MRI to measure brain activity

10 minutes

1 visit (in-person)

Follow-up

Participants are monitored for any immediate post-procedure effects

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tidal Volume set on ventilator

Trial Overview

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

Mechanical ventilation can cause lung injury in patients with ARDS due to factors like pressure settings and duration of use, leading to conditions such as volutrauma and atelectrauma.

Current strategies using a tidal volume of 6 ml/kg can reduce but not completely prevent these injuries, highlighting the need for improved monitoring and innovative technologies to optimize ventilator settings in real-time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Lung protective ventilation - pathophysiology and diagnostics]. Uhlig, S., Frerichs, I.[2020]

Using protective ventilator settings, including reduced tidal volumes and appropriate positive end-expiratory pressure, is crucial for managing patients with acute respiratory distress syndrome (ARDS) to minimize lung injury.

Current evidence supports the importance of preserving spontaneous breathing for at least 48 hours after ARDS onset, highlighting the need for individualized ventilatory strategies based on the patient's condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ventilation in acute respiratory distress. Lung-protective strategies]. Bruells, CS., Rossaint, R., Dembinski, R.[2021]

In a study of 829 mechanically ventilated patients, those with acute lung injury (ALI) or ARDS were given lower tidal volumes (VT) compared to those without, with a median VT of 7.96 mL/kg compared to 8.45 mL/kg, indicating a clinical response to the risk of lung injury.

Despite the use of lower tidal volumes in patients at risk for ALI/ARDS, the initial VT was not linked to the development of post-intubation ALI/ARDS or worse outcomes, suggesting that other factors may influence these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contemporary ventilator management in patients with and at risk of ALI/ARDS. Chang, SY., Dabbagh, O., Gajic, O., et al.[2021]

In a study involving 44 anesthetized rabbits, using a higher positive end-expiratory pressure (PEEP at 12 cm H2O) and a shorter inspiratory time (0.45 seconds) significantly improved gas exchange and lung compliance, suggesting these settings may help prevent ventilator-induced lung injury.

As lung injury developed, the study observed an increase in tidal volume and a change in the airway pressure waveform, indicating that monitoring these parameters could be important in managing ventilator settings to minimize lung damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of ventilatory pattern on experimental lung injury caused by high airway pressure. Simonson, DA., Adams, AB., Wright, LA., et al.[2019]

A retrospective study of 139 patients who experienced out-of-hospital cardiac arrest showed that the use of lower tidal volume (Vt) settings in mechanical ventilation has increased over the years, with a significant correlation to the presence of pulmonary edema.

However, while lower Vt values (<10 mL/kg) were associated with a higher incidence of atelectasis (61.1% vs 36.7% for traditional Vt), there were no differences in pneumonia rates or other respiratory outcomes, suggesting a trade-off in safety with the use of lower Vt.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing pattern of ventilator settings in patients without acute lung injury: changes over 11 years in a single institution. Wongsurakiat, P., Pierson, DJ., Rubenfeld, GD.[2020]

Two randomized controlled trials have established that using lower tidal volumes in patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) reduces morbidity and mortality, leading to current guidelines recommending this practice for ALI/ARDS patients.

For patients without ALI/ARDS, while large observational studies suggest that high tidal volumes may cause lung injury, smaller randomized trials have not definitively proven the benefits of lower tidal volumes, indicating a need for further research to establish safe ventilation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung-protective mechanical ventilation with lower tidal volumes in patients not suffering from acute lung injury: a review of clinical studies. Schultz, MJ.[2020]

In a study of 60 mechanically ventilated patients, using an intratracheal catheter to set tidal volume (TV) and positive end-expiratory pressure (PEEP) resulted in significantly better PEEP levels and improved PaO2/FiO2 ratios by day 7 compared to conventional methods.

The findings suggest that monitoring respiratory mechanics with an intratracheal catheter provides more accurate ventilator settings, which may help prevent alveolar collapse and injury in intensive care unit patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of Tidal Volume and Positive End-Expiratory Pressure on Alveolar Recruitment Using Spiro Dynamics in Mechanically Ventilated Patients. Saxena, S., Tripathi, M., Kumar, V., et al.[2022]

In a study of 14 tracheotomized patients in an intensive care unit, the mode of mechanical ventilation significantly influenced the incidence of tracheal aspiration, with higher rates observed in those using pressure controlled ventilation.

Sedation levels and the duration of mechanical ventilation did not show a significant relationship with tracheal aspiration, indicating that further research is needed to explore these factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of tracheal aspiration in tracheotomized patients in use of mechanical ventilation. Simão, Mde A., Alacid, CA., Rodrigues, KA., et al.[2019]

An electronic algorithm was developed to monitor ventilator settings in real-time, alerting healthcare providers to potentially harmful settings, which was tested on 1,159 patients in intensive care units.

After implementing the alert system, the average exposure to potentially injurious ventilation settings significantly decreased from 40.6 hours to 26.9 hours, indicating improved safety in ventilator care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limiting ventilator-induced lung injury through individual electronic medical record surveillance. Herasevich, V., Tsapenko, M., Kojicic, M., et al.[2010]

In a study of 3,147 ICU patients, those with acute lung injury (ALI) or ARDS had significantly higher mortality rates (38.9% ICU mortality) compared to those without these conditions, highlighting the severity of ALI/ARDS.

The use of higher tidal volumes (> 7.4 mL/kg) and a positive fluid balance were identified as independent risk factors for increased mortality in ALI/ARDS patients, suggesting that ventilatory strategies and fluid management are critical in improving outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High tidal volume and positive fluid balance are associated with worse outcome in acute lung injury. Sakr, Y., Vincent, JL., Reinhart, K., et al.[2022]

Data collected on day 2 of mechanical ventilation, such as the PaO2/FiO2 ratio and peak pressures, can help predict patient outcomes, including the risk of complications and mortality, based on a review of 281 patient episodes.

A low PaO2/FiO2 ratio (<100) is linked to higher mortality, while a higher BMI (>30 kg/m²) is associated with lower mortality, indicating that both respiratory function and body weight are important factors in managing patients on mechanical ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peak Pressures and PaO2/FiO2 Ratios Are Associated With Adverse Outcomes in Patients on Mechanical Ventilators. Whiting, J., Edriss, H., Yang, S., et al.[2018]

Postoperative pulmonary complications significantly impact patient outcomes and healthcare resources, making it crucial to predict and manage these risks, especially in high-risk groups like those with chronic obstructive pulmonary disease or obstructive sleep apnea.

Current research is focusing on optimizing intra-operative ventilation strategies and postoperative care techniques, such as lung-protective ventilation and non-invasive support methods, to reduce the incidence of these complications, although more evidence-based guidelines are still needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory complications of anaesthesia. Mills, GH.[2019]

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