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OpenTrials
Completed

NCT Number: NCT01422681

Extracorporeal CO2 Removal in COPD Exacerbation

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.

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Key information

Conditions

COPD Exacerbation Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Turin, Department of Anesthesia and Intensive Care Medicine

Turin, Italy, 10126

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

minimally invasive extracorporeal carbon dioxide removal

Device

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 outcomes

  1. number of patients treated with the Decap Smart failing NIV and therefore needing endotracheal intubation

    Time frame: 1 month

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

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

Acronym: DECOPD

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 24, 2011
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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