Extracorporeal CO2 Removal in COPD Exacerbation

NCT01422681 | Completed Phase 2

• 1 other identifier: DECOPD1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Exacerbation

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

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

  1 month

Secondary Outcomes (4)

• Adverse events

  1 month

• Hospital length of stay

  18 months

• ICU length of stay

  18 months

• Hospital mortality

  60 days

Study Arms (1)

DECOPD

EXPERIMENTAL

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

Interventions

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).

DECOPD

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

University of Turin, Department of Anesthesia and Intensive Care Medicine

Turin, Italy, 10126, Italy

Location

Related Publications (1)

• Del Sorbo L, Pisani L, Filippini C, Fanelli V, Fasano L, Terragni P, Dell'Amore A, Urbino R, Mascia L, Evangelista A, Antro C, D'Amato R, Sucre MJ, Simonetti U, Persico P, Nava S, Ranieri VM. Extracorporeal Co2 removal in hypercapnic patients at risk of noninvasive ventilation failure: a matched cohort study with historical control. Crit Care Med. 2015 Jan;43(1):120-7. doi: 10.1097/CCM.0000000000000607.

  PMID: 25230375 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• V. Marco Ranieri, MD

  University of Turin, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Professor

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 24, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

IT (1)