Extracorporeal CO2 Removal in COPD Exacerbation

Phase 2

Completed

• Conditions: COPD Exacerbation
• Interventions: Device: minimally invasive extracorporeal carbon dioxide removal

• Registration Number: NCT01422681
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-23
• Study First Posted: 2011-08-24
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-20
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DECOPD	minimally invasive extracorporeal carbon dioxide removal	patients with severe COPD exacerbation on NIV treated with the minimally invasive extracorporeal carbon dioxide removal device (Decap Smart)

Primary Outcome Measures

Name	Time	Method
number of patients treated with the Decap Smart failing NIV and therefore needing endotracheal intubation	1 month

Secondary Outcome Measures

Name	Time	Method
Adverse events	1 month
Hospital length of stay	18 months
ICU length of stay	18 months
Hospital mortality	60 days

Trial Locations

Locations (1)

University of Turin, Department of Anesthesia and Intensive Care Medicine; 🇮🇹 Turin, Italy