Clinical trial NCT01422681: Extracorporeal CO2 Removal in COPD Exacerbation
Official title: Extracorporeal Carbon Dioxide Removal in Patients With Severe COPD Exacerbation Failing Noninvasive Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COPD Exacerbation
Keywords: COPD
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2011-08-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: number of patients treated with the Decap Smart failing NIV and therefore needing endotracheal intubation
timeFrame: 1 month
Secondary outcomes:
measure: Adverse events
timeFrame: 1 month
measure: Hospital length of stay
timeFrame: 18 months
measure: ICU length of stay
timeFrame: 18 months
measure: Hospital mortality
timeFrame: 60 days
Other outcomes:
Locations:
city: Turin
country: Italy
facility: University of Turin, Department of Anesthesia and Intensive Care Medicine
Study officials:
affiliation: University of Turin, Italy
name: V. Marco Ranieri, MD
role: STUDY_DIRECTOR
References:
citation: 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.