Extracorporeal CO2 Removal in COPD Exacerbation (DECOPD)

University of Turin

Status and phase

Completed

Phase 2

Conditions

COPD Exacerbation

Treatments

Device: minimally invasive extracorporeal carbon dioxide removal

Study type

Interventional

Funder types

Other

Identifiers

NCT01422681

DECOPD1

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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)