Effect of Extracorporeal CO2 Removal in Stable Hypercapnic COPD Patients
NCT ID: NCT02260583
Last Updated: 2017-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
15 participants
INTERVENTIONAL
2014-10-31
2018-12-31
Brief Summary
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Only very few studies demonstrated the clinical efficacy of NIV. Indeed this technique is not always well tolerated and therefore it may be effective only in a subset of patients The aim of this study is to assess the feasibility and safety of "one shot" extrcorporeal CO2 removal device, in reducing the PaCO2 level
Detailed Description
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Only very few studies demonstrated the clinical efficacy of NIV. Indeed this technique is not always well tolerated and therefore it may be effective only in a subset of patients Recently extracorporeal CO2 removal have been shown to avoid the need of endotracheal intubation in COPD patients with an episode of Acute Hypercapnic Respiratory Failure In this pilot physiological study we want to assess the safety and efficacy of this technique in reducing the PaCO2 level in those COPD patients with chronic hypercapnic respiratory failure non responding to chronic NIV.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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extracorporeal CO2 removal device
the patients will be enroll to start a "one shot" session of extracorporeal CO2 removal. The patient will be connected to the device via a double lumen catheter inserted in the femoral vein An ECCO2R device based on a modified continuous venovenous hemofiltration system will be used. Blood flow is driven by a roller nonocclusive pump (0-450 mL/min) through a polypropylene oxygenator ; priming volume, 100 mL; contact surface area, 1.35 m2; maximum blood flow rate, 7 L/min) that is connected to a fresh gas flow source delivering 100% oxygen at a constant rate of 8 L/min. Exiting the oxygenator, blood is driven to a hemofilter.
extracorporeal CO2 device
An ECCO2R device based on a modified continuous venovenous hemofiltration system will be used
Interventions
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extracorporeal CO2 device
An ECCO2R device based on a modified continuous venovenous hemofiltration system will be used
Eligibility Criteria
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Inclusion Criteria
* stable PaCO2 \>55 mmHg non respondent to long-term NIV (at least one week). This means a decrease in PaCO2 during spontaneous breathing, at least 4 hrs after the termination of NIV, of\< 6%
* pH \> 7.35
* clinical stability
Exclusion Criteria
* contra-indication to heparin
* Body Mass Index (BMI) \> 30 kg/m2;
* presence of sleep apnea or overall syndrome
18 Years
90 Years
ALL
No
Sponsors
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
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dr. Stefano Nava
PRofessor of Respiratory Medicine
Principal Investigators
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stefano nava
Role: PRINCIPAL_INVESTIGATOR
sant'orsola malpighi hospital
Locations
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san'Orsola Malpighi Hospital, Bologna ITALY
Bologna, , Italy
Countries
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Central Contacts
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Facility Contacts
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stefano nava, md
Role: primary
lara pisani, md
Role: backup
Other Identifiers
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176/2013
Identifier Type: -
Identifier Source: org_study_id