Extracorporeal CO2 Removal in COPD Exacerbation

Study Overview
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Brief Summary
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The minimally invasive extracorporeal carbon dioxide removal may decrease the respiratory load during chronic obstructive pulmonary disease (COPD) exacerbation, reducing the need to advance the respiratory care toward invasive mechanical ventilation in patients refractory to non-invasive ventilatory support (NIV), or decreasing the need of ventilatory support in patients already invasively ventilated, thereby accelerating the weaning process. The investigators intend to perform a multi-center experimental non randomized single arm prospective study to investigate the efficacy of the Decap Smart in reducing the intubation rate or the duration of invasive mechanical ventilation in patients with COPD treated either with NIV or invasive mechanical ventilation (IMV) for severe respiratory failure and hypercapnia. The results of the study will be compared to the data available in the literature.

Official Title
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Extracorporeal Carbon Dioxide Removal in Patients With Severe COPD Exacerbation Failing Noninvasive Ventilation

Conditions
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COPD Exacerbation

Intervention / Treatment
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* Device: minimally invasive extracorporeal carbon dioxide removal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD severe acute respiratory failure after at least two hours of continuous application of non-invasive ventilatory support (NIV): arterial pH ≤7.30 with an arterial pressure of CO2 (PaCO2) >20% of the baseline value and one of the following: respiratory rate ≥30 breaths/min; use of accessory muscles or paradoxical abdominal movements Exclusion Criteria: failure to obtain consent hemodynamic instability (MAP < 60 mmHg) despite infusion of vasoactive drugs contraindications to the administration of i.v. heparin (heparin induced thrombocytopenia, hemorrhage, etc.) body weight >120 kg contraindication to continuation of active treatment (DNR)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DECOPD<br>patients with severe COPD exacerbation on NIV treated with the minimally invasive extracorporeal carbon dioxide removal device (Decap Smart) | Device: minimally invasive extracorporeal carbon dioxide removal<br>* The application of the extracorporeal carbon dioxide removal will be initiated by using a modified continuous veno-venous hemofiltration system equipped with a membrane lung with a total membrane surface of 1,35 m2 (Decap® Smart). Femoral vein is accessed via a double lumen catheter (14 F) inserted with the Seldinger technique and connected with the extracorporeal circuit. Blood flow is driven through the circuit by a roller nonocclusive low-flow pump (0- 450 ml/min) through a membrane lung (Euroset) that is connected to a fresh gas flow source delivering 100% oxygen at a constant rate of 8 l/min. Exiting the membrane lung, blood is driven to a hemofilter (Medica D250). The resulting plasmatic water is recirculated through the membrane lung by a peristaltic pump (0-155 ml/min).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients treated with the Decap Smart failing NIV and therefore needing endotracheal intubation |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 1 month | 
| Hospital length of stay |  | 18 months | 
| ICU length of stay |  | 18 months | 
| Hospital mortality |  | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD