Venovenous CO2 Removal (VVCO2R) in Patients With COPD and Acute Respiratory Failure

Study Overview
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Brief Summary
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The purpose of this study to determine the safety and effectiveness of a mechanical device to remove carbon dioxide from the blood of patients with chronic obstructive pulmonary disease (COPD)when they are hospitalized in the intensive care unit for exacerbation of their condition.

Detailed Description
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This is a pilot study to examine the efficacy and safety of an extracorporeal circuit to remove carbon dioxide (CO2) from the blood in patients with an acute exacerbation of COPD resulting in acute or acute on chronic respiratory failure. The extracorporeal circuit consists of venovenous configuration through a percutaneously inserted 18 F double lumen catheter placed in a central vein. Centrifugal pump and heparin bonded circuit are used and patient is heparinized to maintain an activated clotting time (ACT) > 180. Circuit blood flow and gas sweep speed will be adjusted to maximize CO2 removal and minimize ventilator settings and patient's work of breathing. Patients will remain on the extracorporeal circuit for a maximum of four days as tolerated. Plasma Hemoglobin will be monitored daily.

Official Title
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Safety and Efficacy of Venovenous Carbon Dioxide Removal in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Acute Respiratory Failure (ARF)

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Device: Venovenous CO2 Removal (VVCO2R) in COPD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute respiratory failure on invasive mechanical ventilation or Acute respiratory failure and an advanced directive foregoing invasive mechanical ventilation Established diagnosis of COPD Age group: 18 years or greater Exclusion Criteria: Significant vasopressor support Systolic BP < 100 torr systolic despite vasopressor support Class III or Class IV congestive heart failure Left ventricular ejection fraction < 30% by previous echocardiogram Recent (6 month) history of myocardial infarction Coronary artery disease with unstable angina Recent (6 month) history of venous embolism Uncontrolled coagulopathy (international normalized ratio (INR) > 5 or activated partial thromboplastin time (aPTT) > 80s) despite corrective therapy History of heparin-induced thrombocytopenia or other adverse event following the administration of heparin (heparin group only) Pregnancy Severe chronic liver disease Severe anemia (Hgb < 9 gm/dl) Any contraindication to systemic anticoagulation with heparin, including recent central nervous system injury or hemorrhage, retinal hemorrhage or other recent hemorrhage from sites which cannot be controlled Technically unable to access vessels (obesity, limb deformity, previous surgery at the site, infection, etc.) Evidence of increased intracranial pressure or history of an intracranial hemorrhage within the past 3 months

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: Venovenous CO2 Removal (VVCO2R) in COPD<br>All patients enrolled in the trial will receive VVCO2R which consists of a circuit with a centrifugal pump, tubing, double lumen intravenous catheter and hollow fiber oxygenator | Device: Venovenous CO2 Removal (VVCO2R) in COPD<br>* Patients who meet criteria will be placed on an extracorporeal circuit consisting of an oxygenator, centrifugal pump, tubing and indwelling double lumen venous catheter for CO2 removal for up to 96 hours for treatment of COPD exacerbation requiring hospitalization and intensive care<br>* Other names: (VVCO2R);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Amount of CO2 Transferred Through the Oxygenator at Various Levels of Blood and Gas Flow | The amount of CO2 removed in cc/min will be recorded. The level of blood flow (ml/min) and gas flow (l/min) at each measurement of CO2 removal will also be recorded | 0 to 96 hours |