Mode Of Ventilation During Critical IllnEss Pilot Trial

Study Overview
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Brief Summary
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Landmark trials in critical care have demonstrated that, among critically ill adults receiving invasive mechanical ventilation, the use of low tidal volumes and low airway pressures prevents lung injury and improves patient outcomes. Limited evidence, however, informs the best method of mechanical ventilation to achieve these targets. To provide mechanical ventilation, clinicians must choose between modes of ventilation that directly control tidal volumes (volume control), modes that directly control the inspiratory airway pressure (pressure control), and modes that are hybrids (adaptive pressure control). Whether the choice of the mode used to target low tidal volumes and low inspiratory plateau pressures affects clinical outcomes for critically ill adults receiving mechanical ventilation is unknown. All three modes of mechanical ventilation are commonly used in clinical practice. A large, multicenter randomized trial comparing available modes of mechanical ventilation is needed to understand the effect of each mode on clinical outcomes. The investigators propose a 9-month cluster-randomized cluster-crossover pilot trial evaluating the feasibility of comparing three modes (volume control, pressure control, and adaptive pressure control) for mechanically ventilated ICU patients with regard to the outcome of days alive and free of invasive mechanical ventilation.

Official Title
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Mode Of Ventilation During Critical Illness Pilot Trial

Conditions
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Respiratory Failure

Intervention / Treatment
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* Other: Volume Control mode
* Other: Pressure Control mode
* Other: Adaptive Pressure Control mode


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Receiving mechanical ventilation through an endotracheal tube or tracheostomy Admitted to the study ICU Exclusion Criteria: Patient is pregnant Patient is a prisoner Patient receiving invasive mechanical ventilation at place of residence prior to hospital admission Patient receiving extracorporeal membrane oxygenation at the time of admission to the study ICU

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: In the MODE trial, the entire study ICU will be assigned to a single mode for continuous mandatory ventilation and the ICU will switch between volume control, pressure control, and adaptive pressure control every month in a randomly generated sequence (cluster-crossover).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Volume Control mode<br>During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation. | Other: Volume Control mode<br>* Volume Control mode for mechanical ventilation<br>|
| Active Comparator: Pressure Control mode<br>During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation. | Other: Pressure Control mode<br>* Pressure Control mode for mechanical ventilation<br>|
| Active Comparator: Adaptive Pressure Control mode<br>During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation. | Other: Adaptive Pressure Control mode<br>* Adaptive Pressure Control mode for mechanical ventilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator-free days (VFDs) to day 28 after enrollment | Number of days alive and free from invasive mechanical ventilation between the final liberation from invasive mechanical ventilation before 28 days and study day 28. Patients who continue to receive invasive mechanical ventilation at day 28 or have died prior to day 28 will receive zero VFDs. For patients who return to invasive mechanical ventilation and are subsequently liberated from invasive mechanical ventilation prior to day 28, VFDs will be counted from final liberation from mechanical ventilation. | Enrollment to 28 days |