Extracorporeal CO2 Removal in COPD Exacerbation

COPD Exacerbation Clinical Trial

— DECOPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422681
• Other study ID #: DECOPD1
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2011
• Last updated: January 20, 2014
• Start date: May 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• COPD Exacerbation
• Pulmonary Disease, Chronic Obstructive

Intervention

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).

Locations

Country	Name	City	State
Italy	University of Turin, Department of Anesthesia and Intensive Care Medicine	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients treated with the Decap Smart failing NIV and therefore needing endotracheal intubation		1 month	No
Secondary	Adverse events		1 month	Yes
Secondary	Hospital length of stay		18 months	No
Secondary	ICU length of stay		18 months	No
Secondary	Hospital mortality		60 days	No