Effect of Extracorporeal CO2 Removal in Stable Hypercapnic COPD Patients
- Conditions
- Chronic Respiratory FailureChronic Obstructive Pulmonary Disease Patients
- Registration Number
- NCT02260583
- Brief Summary
Chronic hypercapnic respiratory failure is common in stable COPD patients in a terminal phase of their disease In an attempt to correct or slow down the rate of rise of PaCO2, long-term noninvasive mechanical ventilation (NIV) has been proposed.
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
Chronic hypercapnic respiratory failure is common in stable COPD patients in a terminal phase of their disease In an attempt to correct or slow down the rate of rise of PaCO2, long-term noninvasive mechanical ventilation (NIV) has been proposed.
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
- COPD ( FEV1/CVF <0.70 post bronchodilation)
- 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
- Mean Arterial Pressure < 60 mmHg
- contra-indication to heparin
- Body Mass Index (BMI) > 30 kg/m2;
- presence of sleep apnea or overall syndrome
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method arterial blood gases 30 days
- Secondary Outcome Measures
Name Time Method respiratory rate, dyspnea 30 days
Trial Locations
- Locations (1)
san'Orsola Malpighi Hospital, Bologna ITALY
🇮🇹Bologna, Italy
san'Orsola Malpighi Hospital, Bologna ITALY🇮🇹Bologna, Italystefano nava, mdContact051 6364017stefano.nava@aosp.bo.itlara pisani, mdContact0516363253lara.pisani@unibo.it