EFFECT OF EXTRACORPOREAL CO2 REMOVAL IN STABLE COPD PATIENTS WITH CHRONIC HYPERCAPNIC RESPIRATORY FAILURE:A PILOT STUDY
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease Patients
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- arterial blood gases
- Last Updated
- 8 years ago
Overview
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.
Investigators
dr. Stefano Nava
PRofessor of Respiratory Medicine
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Mean Arterial Pressure \< 60 mmHg
- •contra-indication to heparin
- •Body Mass Index (BMI) \> 30 kg/m2;
- •presence of sleep apnea or overall syndrome
Outcomes
Primary Outcomes
arterial blood gases
Time Frame: 30 days
Secondary Outcomes
- respiratory rate, dyspnea(30 days)