Low-Flow CO2 Removal for Mild to Moderate ARDS With PRISMALUNG

Study Overview
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Brief Summary
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This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of Extracorporeal CO2 removal (ECCO2R) following tidal volume (Vt), and plateau pressure reduction in patients with mild to moderate ARDS.

Detailed Description
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Extracorporeal CO2 removal (ECCO2R) with a low-flow CO2 removal device (Prismalung, Gambro-Baxter) integrated on the Prismaflex platform (Gambro-Baxter) allows tidal volume (Vt) and plateau pressure reduction in patients with mild to moderate ARDS. This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of ECCO2R following Vt and plateau pressure reduction in patients with mild to moderate ARDS. Safety variables during treatment will also be analyzed. A series of 20 consecutive patients will be included in this observational study.

Official Title
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Extracorporeal CO2 Removal (ECCO2R) With a Renal Replacement Platform (PRISMALUNG) to Enhance Lung Protective Ventilation in Patients With Mild to Moderate Acute Respiratory Distress Syndrome (ARDS)

Conditions
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Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Device: CO2 removal with PRISMALUNG in ARDS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mechanical ventilation with expected duration of >24 hours Mild to moderate Acute Respiratory Distress Syndrome (ARDS) according to the Berlin definition: 100 mmHg <PaO2/FiO2 <300 mmHg, with PEEP > 5 cmH2O Exclusion Criteria: Age <18 years Pregnancy Severe hypoxemia with PaO2/FiO2 <100 mmHg Body mass index > 40 kg/m2 Decompensated heart insufficiency or acute coronary syndrome Severe Chronic obstructive pulmonary disease (COPD) Major respiratory acidosis with PaCO2 >60 mmHg Acute brain injury Severe liver insufficiency (Child-Pugh scores >7) or fulminant hepatic failure Heparin-induced thrombocytopenia Contraindication for systemic anticoagulation Patient moribund, decision to limit therapeutic interventions Catheter access to femoral vein or jugular vein impossible Pneumothorax Platelet <50 G/L Lacking consent

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mild to Moderate ARDS on PRISMALUNG<br>Extracorporeal CO2 removal (ECCO2R) with the PRISMALUNG device in patients with mild to moderate Acute Respiratory Distress Syndrome (ARDS). | Device: CO2 removal with PRISMALUNG in ARDS<br>* Observational study of patients with mild to moderate Acute Respiratory Distress Syndrome (ARDS) submitted to Extracorporeal CO2 removal (ECCO2R) with the PRISMALUNG device to allow ultraprotective mechanical ventilation with tidal volume reduction (from 6 to 4 ml/kg, predicted body weight) and plateau pressure reduction from 28-30 to 23-25 cmH2O.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who achieved a tidal volume (Vt) reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values obtained at Vt of 6 mL/kg. | Number of participants who achieved a tidal volume (Vt) reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values obtained at Vt of 6 mL/kg. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of changes in Vt | Assessment of changes in Vt | 24 hours | 
| Assessment of changes in Plateau Pressure | Assessment of changes in Plateau Pressure | 24 hours | 
| Assessment of changes in respiratory rate | Assessment of changes in respiratory rate | 24 hours | 
| Assessment of changes in Positive End-Expiratory Pressure, PEEP | Assessment of changes in Positive End-Expiratory Pressure, PEEP | 24 hours | 
| Change in vasopressor use | Epineprine and norepinephine dose, mcg/kg/min | 24 hours | 
| Evaluation of lung recruitment/derecruitment | With lung echography. Ccording to the method described by Bouhemad et al, Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7 | 24 hours | 
| Lifetime of the extracorporeal circulation | In hours | 7 days | 
| Number of participants with adverse events directly related to ECCO2R | Adverse events directly related to ECCO2R are hemolysis (serum free hemoglobin >500 mg/L), infection at the cannulation site, Hemorrhage at the cannulation site, air entry in the circuit. | 7 days |