Ultra-protective Ventilation Monitored by Electrical Impedance Tomography in Patients With Severe Acute Respiratory Distress Syndrome on Veno-venous ECMO

Study Overview
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Brief Summary
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For ECMO supported patients with severe ARDS (acute respiratory distress syndrome), usual care include use of ultraprotective mechanical ventilation with tidal volume and pressure reductions that might ultimately enhance lung protection of patients with ARDS. Although very low tidal might also cause pulmonary derecruitment. The aim of this study is to monitor effects of very low tidal volume on regression of overdistension and derecruitment using electrical impedance tomography. Secondary aim is to describe the evolution of the optimal PEEP (Positive End Expiratory Pressure) during the decrease of the tidal volume

Detailed Description
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Patients requiring venovenous ECMO support for severe ARDS will be monitored with electrical impedance tomography during introduction of ultraprotective mechanical ventilation. Monitoring will start with pre-ECMO ventilator setting, then the tidal volume will be lowered step by step. Other parameters of the ventilator will be kept constant. Then, cumulated collapse and overdistention percentages will be estimated for each tidal volume. Optimal tidal volume will be defined by the lowest sum of alveolar overdistension and collapse. Also, at the end of each step, PEEP titration will be performed to identify the optimal PEEP setting that combines the best alveolar recruitment with minimal overdistention. The aim is to determine whether the derecruitment induced by the decrease in tidal volume can be reduced by the application of PEP. Then, comparison of the different tidal volumes with application of ideal PEEP will be performed: measurement of the percentage of collapsed and overdistended areas by impedancemetry method between the different levels of tidal volume with application of ideal PEEP.

Official Title
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Ultra-protective Ventilation Monitored by Electrical Impedance Tomography in Patients With Severe Acute Respiratory Distress Syndrome on Veno-venous ECMO

Conditions
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Severe ARDS

Intervention / Treatment
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* Device: Ultra-protective mechanical ventilation monitored by electrical impedance tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged ≥ 18 years patient with ARDS on venovenous (VV)-ECMO Written informed consent patient affiliated to a social security scheme Exclusion Criteria: Pregnancy Adult patient subject to a legal protection measure (tutor, curator, etc.) Patients with a pacemaker, automatic implantable cardioverter defibrillator, contraindications to thoracic belt placement (e.g., thoracic or spinal cord trauma, recent thoracic surgery) undrained pneumothorax, bronchopleural fistula hemodynamic instability (i.e., use of intravenous fluids of more than 10 mL/kg or vasopressors 2 mg/h of norepinephrine or 0.5 mg/h of epinephrine)

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>All patients included | Device: Ultra-protective mechanical ventilation monitored by electrical impedance tomography<br>* A silicone EIT belt will be placed around the patient's thorax (sixth intercostal parasternal space). EIT data will be generated by application of a small alternating electrical current (5 mA at 50 kHz). Introduction of ultraprotective mechanical ventilation will be monitored.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulated collapse and overdistention percentages for each tidal volume by impedancemetry method | Estimating the best lung-compartment compliance, reflected by the number of functional lung units in that region, and current compliance for each pixel, the collapse and overdistention percentages per pixel will be compared for each tidal volume, with constant (pre-ECMO) PEEP. | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal PEEP by impedancemetry method at each tidal volume | PEEP titration will be performed to identify the optimal PEEP setting that combines the best alveolar recruitment with minimal overdistention at each tidal volume | One day | 
| cumulated collapsed and overdistended for each tidal volume by impedancemetry method with application of optimal PEEP | Estimating the best lung-compartment compliance, reflected by the number of functional lung units in that region, and current compliance for each pixel, the collapse and overdistention percentages per pixel will be compared for each tidal volume, with optimal PEEP | One day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECMO, ARDS, ultra-protective mechanical ventilation