Extracorporeal Carbon Dioxide Removal in Patients With Severe COPD Exacerbation Failing Noninvasive Ventilation
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- COPD Exacerbation
- Sponsor
- University of Turin, Italy
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- number of patients treated with the Decap Smart failing NIV and therefore needing endotracheal intubation
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Marco Ranieri
MD Professor
University of Turin, Italy
Eligibility Criteria
Inclusion Criteria
- •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)
Outcomes
Primary Outcomes
number of patients treated with the Decap Smart failing NIV and therefore needing endotracheal intubation
Time Frame: 1 month
Secondary Outcomes
- Adverse events(1 month)
- Hospital length of stay(18 months)
- ICU length of stay(18 months)
- Hospital mortality(60 days)