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Extracorporeal CO2 Removal in COPD Exacerbation (DECOPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01422681
Recruitment Status : Completed
First Posted : August 24, 2011
Last Update Posted : January 22, 2014
Information provided by (Responsible Party):
Marco Ranieri, University of Turin, Italy

Brief 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.

Condition or disease Intervention/treatment Phase
COPD Exacerbation Device: minimally invasive extracorporeal carbon dioxide removal Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: DECOPD
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).

Primary Outcome Measures :
  1. number of patients treated with the Decap Smart failing NIV and therefore needing endotracheal intubation [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 1 month ]
  2. Hospital length of stay [ Time Frame: 18 months ]
  3. ICU length of stay [ Time Frame: 18 months ]
  4. Hospital mortality [ Time Frame: 60 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT01422681

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University of Turin, Department of Anesthesia and Intensive Care Medicine
Turin, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy
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Study Director: V. Marco Ranieri, MD University of Turin, Italy
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Marco Ranieri, MD Professor, University of Turin, Italy Identifier: NCT01422681    
Other Study ID Numbers: DECOPD1
First Posted: August 24, 2011    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014
Keywords provided by Marco Ranieri, University of Turin, Italy:
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases