Ventilation Modes for Critical Illness
(MODEM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if the type of ventilator setting in intensive care affects patients' recovery and survival. It compares three ventilator modes: volume control, pressure control, and adaptive pressure control, to identify which helps patients remain alive and off the breathing machine the longest. Suitable candidates for this trial are those currently on a breathing machine in a participating ICU (Intensive Care Unit). As an unphased trial, it provides patients the opportunity to contribute to significant research that could enhance ventilator care for future patients.
Will I have to stop taking my current medications?
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 modes are safe for critical illness patients?
Research shows that all three ventilator modes—adaptive pressure control, pressure control, and volume control—are generally safe and well-tolerated for patients needing respiratory support in intensive care. Studies have found that these modes can help protect the lungs by maintaining low air pressure and volume.
Data from smaller hospitals suggest that adaptive pressure control is as safe as traditional methods. This mode automatically adjusts to the patient's needs, potentially increasing comfort.
Pressure control ventilation has been studied over the years, with results showing a decrease in death rates among patients using it, indicating its reliability and safety.
Volume control ventilation is widely used and has been part of studies showing better outcomes in hospitals with more patients, demonstrating its safety and effectiveness in critical care.
In summary, research has found all three ventilator modes to be safe for patients in critical care, with no major negative effects reported.12345Why are researchers excited about this trial?
Researchers are excited about the trial on ventilation modes for critical illness because it aims to optimize mechanical ventilation, which is crucial for patients in intensive care. Unlike traditional methods that primarily use fixed pressure or volume settings, this trial explores adaptive pressure control, pressure control, and volume control as separate approaches. These modes could potentially offer more personalized and efficient breathing support, reducing lung injury and improving patient outcomes. By comparing these different methods, researchers hope to identify the best ventilation strategy, providing insights that could lead to more effective and tailored care for critically ill patients.
What evidence suggests that this trial's ventilator modes could be effective for critical illness?
Research has shown that ventilator settings can affect patient recovery in the ICU. This trial will compare adaptive pressure control, pressure control, and volume control settings. Participants in the Adaptive Pressure Control Group will receive ventilation that manages both the air volume and airway pressure. Those in the Pressure Control Group will receive a setting associated with lower death rates over time, suggesting potential benefits. Participants in the Volume Control Group will receive a common method effective with low air volumes. Each setting has strengths, but no single one suits everyone. The best choice depends on the patient's individual needs.26789
Are You a Good Fit for This Trial?
This trial is for patients in intensive care units who require mechanical ventilation due to respiratory impairment or breathing failure. The specific eligibility criteria are not provided, but typically participants would be critically ill individuals on breathing machines.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mechanical ventilation using one of three modes: volume control, pressure control, or adaptive pressure control, assigned to the ICU unit in a randomized sequence every 2 months
Follow-up
Participants are monitored for ventilator-free days, mortality, and other safety outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Ventilator Mode Selection
Trial Overview
The study is testing three different ventilator modes: volume control, pressure control, and adaptive pressure control. It aims to determine which mode improves survival and reduces the time patients need mechanical ventilation by randomly assigning ICU units to one mode at a time.
How Is the Trial Designed?
3
Treatment groups
Active Control
During invasive mechanical ventilation in a study location, adaptive pressure control will be used as the mode for continuous mandatory ventilation.
During invasive mechanical ventilation in a study location, pressure control will be used as the mode for continuous mandatory ventilation.
During invasive mechanical ventilation in a study location, volume control will be used as the mode for continuous mandatory ventilation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Citations
a systematic review and network meta-analysis - PMC
NAVA can reduce mortality in ICU, and PAV may increase the risk of withdrawal of the ventilator. There was no significant difference between PSV and other ...
Mode of Ventilation During Critical Illness at Multiple Centers
The MODEM trial is a cluster-randomized, cluster-crossover clinical trial comparing the effectiveness of three ventilator modes (volume control ...
A Pragmatic Pilot Trial Comparing Patient-Triggered ...
The primary outcome of the trial was adherence to assigned ventilator mode within 1 h of initiation of ICU mechanical ventilation, with a predefined feasibility ...
Comparison Between Synchronized Intermittent Mandatory ...
In critically ill patients, the choice of mechanical ventilation modes can have a significant impact on patient outcomes.
Effectiveness, safety and efficacy of INTELLiVENT ...
Expert opinion: Studies suggest INTELLiVENT–ASV to be an effective automated mode with regard to the titrations of tidal volume, airway pressure, and oxygen.
Protocol and Statistical Analysis Plan for the Mode of ...
Volume control, pressure control, and adaptive pressure control all can achieve low tidal volume and low plateau pressures, the key components of lung ...
Effect of Ventilator Mode on Ventilator-Free Days in ...
This pilot trial establishes the feasibility of conducting a cluster-randomized, crossover trial of ventilator mode among critically ill adults.
Comparison of clinical outcomes in critical patients ...
Conclusion: NAVA can reduce mortality in ICU, and PAV may increase the risk of withdrawal of the ventilator. There was no significant difference ...
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journalmechanicalventilation.com
journalmechanicalventilation.com/wp-content/uploads/2021/07/Automated-mechanical-ventilation-using-Adaptive-Support-Ventilation-versus-conventional-ventilation-.pdfAutomated mechanical ventilation using Adaptive Support ...
The data was collected in a unique access database designed to collect data for assessment of mechanical ventilation outcomes in a small medical center ICU.
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