Ventilator Settings for Mechanical Ventilation

(SEVERE Trial)

Overseen By Irene Telias

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Must not be taking: Neuromuscular blockers

Disqualifiers: Severe neurological disorders, lung transplant, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different ventilator settings affect reverse triggering in critically ill patients on mechanical ventilation. Reverse triggering can cause issues like double breaths but may also help prevent diaphragm weakening. Researchers adjust the ventilator's breath rate and volume (changes in the ventilator respiratory rate and tidal volume) to assess their impact on reverse triggering and muscle activity. Patients who are intubated and on a specific type of ventilator support for more than 12 hours, and have been sedated for at least 6 hours, may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding and potentially improving ventilator care for critically ill patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using continuous neuromuscular blocking agents, you cannot participate in the study.

What prior data suggests that these ventilator setting adjustments are safe for patients under mechanical ventilation?

Studies have shown that adjusting ventilator settings, such as tidal volume and respiratory rate, is generally safe for patients using a breathing machine. Research indicates that the assist-control mode, with preset settings, supports the patient while allowing some independent breathing. Medical practice has well-documented the safety of these settings, suggesting they are usually well-tolerated with few side effects.

For comfort and safety, the ventilator delivers a steady amount of air to assist patients in breathing with minimal effort. This common method aims to balance the support needed with the patient's own breathing efforts. While settings can vary between patients, careful adjustments ensure safety and comfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how adjusting ventilator settings, specifically respiratory rate and tidal volume, might improve outcomes for patients on mechanical ventilation. Unlike standard practices that use a one-size-fits-all approach, this method considers individual patient needs, potentially reducing lung injury and improving recovery. By tailoring ventilation to each patient's condition, the study aims to provide more personalized care, which could lead to better overall results.

What evidence suggests that these ventilator setting adjustments are effective for managing reverse triggering?

Research has shown that changing ventilator settings, such as the speed and volume of air delivered to a patient, can affect recovery. In this trial, researchers will adjust participants' ventilator settings, including respiratory rate and tidal volume. Typically, tidal volume is set to align with common medical practices, around 6–8 mL per kilogram of body weight. Studies indicate that volume-controlled ventilation, where the machine regulates air and breathing rate, can fully support the patient’s breathing. This approach can reduce the effort needed to breathe and maintain steady breathing. Adjusting these settings might help manage reverse triggering, a condition where the machine prompts the patient to breathe instead of the patient doing so naturally. Finding the right settings can enhance patient comfort and protect the lungs. ^{1 3 4 6 7}

Who Is on the Research Team?

Laurent Brochard

Principal Investigator

Unity Health Toronto - St. Michael's Hospital

Are You a Good Fit for This Trial?

This trial is for adult patients who are critically ill and require mechanical ventilation in a mode called assist-control. Participants must be sedated and able to undergo changes in ventilator settings without risk. Specific criteria about health status or other conditions aren't provided, but typically, patients with unstable conditions would be excluded.

Inclusion Criteria

I have been under sedation for at least 6 hours.

Patients intubated for more than 12 hours

With a sedation-agitation score ≤ 4

Exclusion Criteria

History of previous lung transplant

Severe metabolic acidosis (pH < 7.25) at the time of study procedure

History of primary severe neurological disorders

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Ventilator Setting Adjustment

Ventilator settings are adjusted to assess the influence on reverse triggering and respiratory muscle activity.

1 day

Continuous monitoring during hospital stay

Continuous Monitoring

Continuous recording of ventilator waveforms and EEG to investigate intrinsic respiratory rate and brain activity.

24 hours

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after ventilator adjustments.

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Changes in the ventilator respiratory rate and tidal volume

Trial Overview The study is testing how different ventilator settings (respiratory rate and tidal volume) affect the occurrence of reverse triggering—a condition where the ventilator initiates breaths instead of the patient—and its impact on respiratory muscle activity.

How Is the Trial Designed?

Group I: Patients under mechanical ventilation Experimental Treatment 1 Intervention

Patients intubated for more than 12 hours, on assist-control ventilation, not triggering the ventilator with or without reverse triggering, exposed to sedation for at least 6 hours, with a sedation-agitation score ≤ 4.

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Published Research Related to This Trial

A systematic review of 16 studies identified that use errors in mechanical ventilators are often caused by usability issues and the variability in user interfaces across different devices, which can lead to confusion among medical staff.

To reduce these errors, the review suggests that manufacturers should standardize user interface content and implement design recommendations, which could enhance safety and improve risk management in ventilator use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Causes of use errors in ventilation devices - Systematic review. Coldewey, B., Diruf, A., Röhrig, R., et al.[2021]

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 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]

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 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]

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]

A study over two months involving 248 initial assessments (G1) and 250 follow-up assessments (G2) of patients on mechanical ventilation showed significant improvements in the accuracy of ventilation parameters and alarm settings after implementing corrective measures.

The corrective measures led to a generalized reduction in errors across all monitored parameters, indicating that these strategies can enhance patient safety and should be integrated into quality control programs for mechanical ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Control of respiratory monitoring in the critical patient]. Subirana, M., Pascual, S., Jover, C., et al.[2016]

In a study of 243 mechanically ventilated patients, adaptive support ventilation (ASV) adjusted tidal volume (VT) and respiratory rate (RR) based on the patient's lung condition, delivering higher VT and lower RR for COPD patients compared to those with ALI/ARDS.

For patients who actively triggered the ventilator, ASV did not show significant differences in VT-RR combinations across various lung conditions, indicating a potential uniformity in support for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic selection of breathing pattern using adaptive support ventilation. Arnal, JM., Wysocki, M., Nafati, C., et al.[2022]

Nurses can effectively adjust mechanical ventilator settings by using data from various monitoring tools like ABG, pulse oximetry, and capnography, which helps in correcting ventilation and oxygenation issues.

Applying scientific principles consistently in these adjustments not only enhances nursing assessments and interventions but also helps prevent unnecessary discomfort and costs for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The art and science of mechanical ventilator adjustments. Dettenmeier, PA., Johnson, TM.[2004]

In a study of 51,689 adult patients receiving mechanical ventilation across 274 California hospitals, higher hospital ventilation volumes were associated with increased odds of in-hospital death and tracheostomy procedures, suggesting worse outcomes at high-volume centers.

Interestingly, patients at high-volume hospitals had lower odds of 30-day readmission after discharge, indicating a complex relationship between hospital volume and patient outcomes that warrants further investigation into care processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital Mechanical Ventilation Volume and Patient Outcomes: Too Much of a Good Thing? Mehta, AB., Walkey, AJ., Curran-Everett, D., et al.[2020]

A study involving 159 patients in an intensive care unit showed that using predicted body weight based on knee height led to a significant reduction in tidal volume delivered during mechanical ventilation, from 8.97 mL/kg to 7.49 mL/kg, which is important for lung protection.

The intervention, which included education and feedback, resulted in sustained adherence to the new tidal volume guidelines for 12 months, highlighting the effectiveness of this approach in improving mechanical ventilation practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung protection: an intervention for tidal volume reduction in a teaching intensive care unit. Briva, A., Gaiero, C.[2022]

Mechanical ventilation is crucial for patients with acute respiratory failure (ARF), and its application is guided by hemogasanalysis, hemodynamics, and X-ray findings.

The study emphasizes the importance of understanding mechanical measures and their impact on ventilatory strategies to optimize patient outcomes during mechanical ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Traditional artificial ventilation. General principles]. Ranieri, VM.[2006]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK539742/

Mechanical Ventilation - StatPearls - NCBI Bookshelf Tidal volume (VT) should be set to 8 mL/kg, while the initial respiratory rate (RR) should be set at 10 breaths per minute.[30] These settings provide ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK606131/

Adjusting Ventilator Settings Based on ABG Results - NCBI - NIH Adjusting inspiratory flow can affect the distribution of ventilation within the lungs and the patient's work of breathing. Faster flow rates ...

3. associationofanaesthetists-publications.onlinelibrary.wiley.com associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/full/10.1111/anae.16616

Evaluating ventilator settings as related to mechanical power For the same simulated lung mechanics, our data showed that volume-controlled ventilation results in lower generated mechanical power compared ...

4. merckmanuals.com merckmanuals.com/professional/critical-care-medicine/respiratory-failure-and-mechanical-ventilation/overview-of-mechanical-ventilation

Overview of Mechanical Ventilation - Critical Care Medicine V/C ventilation is the simplest and most effective means of providing full mechanical ventilation. In this mode, each inspiratory effort beyond the set ...

5. emedicine.medscape.com emedicine.medscape.com/article/304068-overview

Mechanical Ventilation If the patient does not initiate inspiration, the ventilator automatically delivers the preset rate and tidal volume, ensuring minimum minute ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK526044/

Ventilator Safety - StatPearls - NCBI Bookshelf The ventilator will deliver a set tidal volume regardless of effort by the patient. This mode of ventilation permits the patient to do some breathing and is ...

7. atm.amegroups.org atm.amegroups.org/article/view/19973/html

The basics of respiratory mechanics: ventilator-derived ... Respiratory rate must be adjusted during mechanical ventilation to maintain a minute volume appropriate to the patient's metabolic demands.