A Phase 2 interventional study of minimally invasive extracorporeal carbon dioxide removal in COPD Exacerbation, sponsored by University of Turin, Italy. Completed at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2014-01-22.
Sponsored by University of Turin, Italy · Phase 2, Interventional, and Supportive care
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →University of Turin, Italy is the lead sponsor of 206 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
University of Turin, Italy