Extracorporeal CO2 Removal in COPD Exacerbation (DECOPD)
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|ClinicalTrials.gov Identifier: NCT01422681|
Recruitment Status : Completed
First Posted : August 24, 2011
Last Update Posted : January 22, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|COPD Exacerbation||Device: minimally invasive extracorporeal carbon dioxide removal||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Extracorporeal Carbon Dioxide Removal in Patients With Severe COPD Exacerbation Failing Noninvasive Ventilation|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||December 2013|
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
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).
- number of patients treated with the Decap Smart failing NIV and therefore needing endotracheal intubation [ Time Frame: 1 month ]
- Adverse events [ Time Frame: 1 month ]
- Hospital length of stay [ Time Frame: 18 months ]
- ICU length of stay [ Time Frame: 18 months ]
- Hospital mortality [ Time Frame: 60 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422681
|University of Turin, Department of Anesthesia and Intensive Care Medicine|
|Turin, Italy, 10126|
|Study Director:||V. Marco Ranieri, MD||University of Turin, Italy|