ECCO2R - Mechanical Power Study

Study Overview
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Brief Summary
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Although mechanical ventilation remains the cornerstone of ARDS treatment, several experimental and clinical studies have undoubtedly demonstrated that it can contribute to high mortality through the developing of ventilator induced lung injury even in patients with plateau pressure <30 cmH2O. Since now there are no studies exploring the application of low flow extracorporeal CO2 removal and ultraprotective ventilation to reduce mechanical power, a composite index of VILI, independently from the value of plateau pressure or the severity of hypercapnia.

Official Title
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The Effects of Low Flow Extracorporeal CO2 Removal on Mechanical Power in ARDS Patients

Conditions
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ARDS, Human, Extracorporeal CO2 Removal, Mechanical Power

Intervention / Treatment
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* Other: Extracorporeal CO2 Removal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ARDS patients undergoing mechanical ventilation with: PaO2/FiO2 <150 with a level of positive end expiratory pressure (PEEP) of 10 cmH2O or higher with a FiO2 > 0.5 Plateau pressure of 28 cmH2O or higher with tidal volume of 6 ml/Kg of ideal body weight Mechanical power of 18 J/min or higher. Exclusion Criteria: <18 years of age Pregnancy Obesity with BMI> 30 Platelets <30 G/l Decompensated heart failure or acute coronary syndrome Acute brain injury Contraindication for systemic anticoagulation (for example, gastrointestinal bleeding, recent cerebrovascular accident, or chronic bleeding disorder, recent major surgery) Patient moribund, decision to limit therapeutic interventions Catheter access to femoral vein or jugular vein impossible Pneumothorax.

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Extracorporeal CO2 Removal|Extracorporeal carbon dioxide removal (ECCO2R), a low flow extracorporeal CO2 removal, may be used in association with ultraprotective mechanical ventilation (tidal volume < 6 ml/kg and Pplat <20-25 cmH2O).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical Power reduction. | Achievement of Mechanical Power reduction under 18 J/min while maintaining pH and PaCO2 to ± 20% of baseline values obtained at tidal volume of 6 mL/kg. Mechanical Power (MP) (J/min) = 0.098 * respiratory rate * tidal volume (inspiratory peak airway pressure - 1/2 * (airway pressure at end inspiratory pause - airway pressure at PEEP)) | Changes from baseline to day 5. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory mechanics. | 1. Respiratory system elastance (Ers) (cmH2O/L) = (airway pressure at end inspiratory pause - airway pressure at PEEP) / tidal volume | Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days | 
| Respiratory mechanics. | 2. Lung elastance (El) (cmH2O/L) = (transpulmonary pressure at end inspiratory pause - transpulmonary pressure at PEEP / tidal volume | Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days | 
| Respiratory mechanics. | 3. Chest wall elastance (Ecw) (cmH2O/L) = (esophageal pressure at end inspiratory pause - esophageal pressure at PEEP) / tidal volume | Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days | 
| Respiratory mechanics. | 4. End inspiratory transpulmonary pressure (cmH2O)= airway pressure at end inspiratory pause - (esophageal pressure at end inspiratory pause - expiration at atmospheric pressure by a release manouvre). | Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days | 
| Gas exchange. | Assessment of changes in PaCO2 mmHg. | Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days | 
| Gas exchange. | Assessment of changes in PaO2 mmHg. | Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days | 
| Gas exchange. | Assessment of changes in PaO2/FiO2. | Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days | 
| Safety assessment and adverse device related events: frequency of serious adverse events | Safety assessment reporting frequency of serious adverse events in terms of device related mechanical events (Pump malfunction, membrane lung clotting, system leaks, tubing rupture, air in the circuit) and device related clinical events (heamolysis, significant bleeding, thromboembolic complications, neurologic complications, metabolic complications). | Every day, until the fifth day or until the weaning from ECCO2R if lower than five days |