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

Not Applicable

Terminated

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Venovenous CO2 Removal (VVCO2R) in COPD	Venovenous CO2 Removal (VVCO2R) in COPD	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

Primary Outcome Measures

Name	Time	Method
The Amount of CO2 Transferred Through the Oxygenator at Various Levels of Blood and Gas Flow	0 to 96 hours	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

Secondary Outcome Measures