NCT01422681

Extracorporeal CO2 Removal in COPD Exacerbation

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• COPD Exacerbation

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-11-01
• Completion: 2013-12-01
• First posted: 2011-08-24
• Last updated: 2014-01-22

Locations

1 site across 1 country: Italy