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

The University of Texas System (UT)

Status: Terminated

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Device: Venovenous CO2 Removal (VVCO2R) in COPD

Study type: Interventional

Funder types: Other

Identifiers

NCT00594009

03-142

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Acute respiratory failure on invasive mechanical ventilation or
2. Acute respiratory failure and an advanced directive foregoing invasive mechanical ventilation
3. Established diagnosis of COPD
4. Age group: 18 years or greater

Exclusion criteria

1. Significant vasopressor support
2. Systolic BP < 100 torr systolic despite vasopressor support
3. Class III or Class IV congestive heart failure
4. Left ventricular ejection fraction < 30% by previous echocardiogram
5. Recent (6 month) history of myocardial infarction
6. Coronary artery disease with unstable angina
7. Recent (6 month) history of venous embolism
8. Uncontrolled coagulopathy (international normalized ratio (INR) > 5 or activated partial thromboplastin time (aPTT) > 80s) despite corrective therapy
9. History of heparin-induced thrombocytopenia or other adverse event following the administration of heparin (heparin group only)
10. Pregnancy
11. Severe chronic liver disease
12. Severe anemia (Hgb < 9 gm/dl)
13. 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
14. Technically unable to access vessels (obesity, limb deformity, previous surgery at the site, infection, etc.)
15. Evidence of increased intracranial pressure or history of an intracranial hemorrhage within the past 3 months

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Venovenous CO2 Removal (VVCO2R) in COPD

Experimental group

Description:

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

Treatment:

Device: Venovenous CO2 Removal (VVCO2R) in COPD