Extracorporeal CO2 Removal in Hypercapnic Patients

Study Overview
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Brief Summary
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Noninvasive ventilation represents the standard of care for patients with exacerbation of chronic obstructive pulmonary disease. However, NIV fails in almost 30% of the most severe forms of acute hypercapnic respiratory failure and patients must undergo endotracheal intubation and invasive ventilation to restore adequate gas exchange. Under these circumstances, patients may express a clear intention not to be intubated.The aim of this study is to retrospectively assess efficacy and safety of noninvasive ventilation- plus-extracorporeal Co2 removal in patients who fail NIV and refuse endotracheal intubation.

Detailed Description
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During a period of two years (from January 2013 to July 2015) 35 patients with acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease, refused endotracheal intubation after failing NIV and were treated with extracorporeal Co2 removal plus NIV as last resort therapy. The collected data of these patients will be retrospectively matched with data obtained from 35 historical controls who received conventional treatment with endotracheal intubation. The study will retrospectively compare intubation rate, acid base homeostasis, norepinephrine requirements (in the patients who due to clinical conditions were under norepinephrine before starting extracorporeal Co2 removal ) and coagulation parameters.

Official Title
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Extracorporeal CO2 Removal in Hypercapnic Patients Who Failed Noninvasive Ventilation and Refuse Endotracheal Intubation: a Case Series

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Device: LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: exacerbation of chronic obstructive pulmonary disease failure of non invasive ventilation expression of a clear intention not to be intubated Exclusion Criteria: alterations in mental status which do not allow to express a clear intention not to be intubated contraindications to anticoagulation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hypercapnic patients<br>patients with acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease, refused endotracheal intubation after failing NIV and were treated withLow flow etracorporeal CO2 removal | Device: LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients who avoided endotracheal intubation |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gas exchange homeostasis | pH, PaCO2, PaO2, bicarbonate, arterial lactate | 96 hrs | 
| Norepinephrine requirements | norepinephrine requirements in the patients who due to clinical conditions were under norepinephrine before starting the treatment with extracorporeal Co2 removal | 30 days | 
| coagulation | INR, pt, ptt. platelets | 30 days | 
| Day 28 mortality |  | 28 days | 
| intra hospital mortality |  | 180 days |