Safety and Efficacy of Venovenous Carbon Dioxide Removal in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Acute Respiratory Failure (ARF)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- The Amount of CO2 Transferred Through the Oxygenator at Various Levels of Blood and Gas Flow
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •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
研究组 & 干预措施
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
干预措施: Venovenous CO2 Removal (VVCO2R) in COPD (Device)
结局指标
主要结局
The Amount of CO2 Transferred Through the Oxygenator at Various Levels of Blood and Gas Flow
时间窗: 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
次要结局
未报告次要终点