Generating Evidence in ECMO Ventilation Strategies

Study Overview
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Brief Summary
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The goal of this pilot clinical trial is to test if ICU level ventilator protocols are appropriate interventions to study differences in ventilator strategies for patients with acute respiratory failure supported by VV-ECMO. The main questions it aims to answer are: will clinicians closely follow different ICU ventilator protocols will different ICU ventilator protocols change the way that patients are treated. Participants will be assigned to one of two ventilator protocols based on the month that they are first started on ECMO. Researchers will compare standard lung-protective ventilation to ultra-lung protective ventilation protocols to see how this changes how the ventilator is set for patients.

Detailed Description
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This is a pilot, open label, pragmatic cluster-crossover clinical trial testing the feasibility and exploring the clinical impact of ICU-level ventilator management protocols as interventions in patients with acute respiratory failure requiring support with extracorporeal membrane oxygenation (ECMO). The overall objective is to inform the design of a future pragmatic, cluster-randomized clinical trial. The investigators will do this by completion of the following aims: Aim 1: Measure clinician fidelity to ICU-level ventilator management protocols for patients with ARDS treated with ECMO. Hypothesis: Clinicians will have high fidelity to ICU-level ventilator management protocols for patients with severe ARDS on ECMO. To test this hypothesis, the investigators will conduct a pilot cluster-crossover study. The Duke medical ICU will be treated as a single cluster of patients. This cluster will be assigned to a standard lung-protective ventilation protocol for patients treated with ECMO, and then crossover to an ultra-lung protective ventilation protocol. The investigators will record if patient ventilator settings adhere to the assigned protocol at the time of treatment. The proportion of patients whose ventilator settings adhere to the assigned protocol will be compared to an a priori defined threshold to indicate feasibility. Aim 2: Explore the clinical impact of using different ventilator management protocols for patients with ARDS treated with ECMO. Hypothesis: Patients managed with standard lung protective ventilation will have shorter durations of ECMO and mechanical ventilation when compared with patients managed with ultra-lung protective ventilation. To test this hypothesis, the investigators will measure the duration of ECMO and mechanical ventilation for all patients enrolled in the study. The investigators will perform an exploratory analysis examining differences in these outcomes between the two treatment groups.

Official Title
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Generating Evidence in ECMO Ventilation Strategies - A Pilot Study

Conditions
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ARDS, Acute Respiratory Failure

Intervention / Treatment
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* Other: Standard-Lung Protective Ventilation
* Other: Ultra-Lung Protective Ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients being treated with ECMO in the Duke University Hospital Medical ICU will be eligible Exclusion Criteria: There are no exclusion criteria

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: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard-Lung Protective Ventilation<br> | Other: Ultra-Lung Protective Ventilation<br>* ICU ventilator protocol adhering to the following lung protective ventilation strategy: Plateau Pressure ≤ 30 cm of water PEEP and FiO2 set according to ARDSnet table Driving Pressure ≤ 15 cm of water Respiratory rate between 8 and 30 breaths per minute<br>|
| Active Comparator: Ultra-Lung Protective Ventilation<br> | Other: Standard-Lung Protective Ventilation<br>* ICU ventilator protocol adhering to the following lung protective ventilation strategy: Plateau Pressure ≤ 30 cm of water PEEP and FiO2 set according to ARDSnet table Driving Pressure ≤ 15 cm of water Respiratory rate between 8 and 30 breaths per minute<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protocol fidelity rate | Percentage of days that a patient's ventilator settings adhere to assigned protocol | From study enrollment until removal of ECMO support or death, whichever comes first, up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of ECMO | Total number of days a patient is supported with ECMO | From study enrollment until removal of ECMO support or death, whichever comes first, up to 52 weeks | 
| Duration of mechanical ventilation | Total number of days a patient is supported with mechanical ventilation | From study enrollment until removal of mechanical ventilatory support or death, whichever comes first, up to 52 weeks | 
| Duration of ICU admission | Total number of days a patient is cared for in the ICU | From study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks | 
| Duration of Hospital admission | Total number of days patient is admitted to the hospital | From study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks | 
| Survival to discharge | Whether a patient survives until hospital discharge | From study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks | 
| Time to meeting criteria for ECMO weaning | Total number of days between enrollment and when a patient meets criteria for ECMO weaning | From study enrollment until meeting weaning criteria or death, whichever comes first, up to 52 weeks | 
| Time to first ECMO weaning trial | Total number of days between enrollment and when a patient first has an ECMO weaning trial | From study enrollment until first weaning trial or death, whichever comes first, up to 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extracorporeal membrane oxygenation, mechanical ventilation, lung protective ventilation, ultra-lung protective ventilation