Extracorporeal CO2 Removal With the Hemolung RAS for Mechanical Ventilation Avoidance During Acute Exacerbation of COPD
Extracorporeal CO2 Removal With the Hemolung RAS for Mechanical Ventilation Avoidance During Acute Exacerbation of COPD
This study evaluates the safety and efficacy of using the Hemolung RAS to provide low-flow
 extracorporeal carbon dioxide removal (ECCO2R) as an alternative or adjunct to invasive
 mechanical ventilation for patients who require respiratory support due to an acute
 exacerbation of Chronic Obstructive Pulmonary Disease (COPD). It is hypothesized that the
 Hemolung RAS can be safely used to avoid or reduce time on invasive mechanical ventilation
 compared to COPD patients treated with standard-of-care mechanical ventilation alone.
 Eligible patients will be randomized to receive lung support with either the Hemolung RAS
 plus standard-of-care mechanical ventilation, or standard-of-care mechanical ventilation
 alone.
The Hemolung RAS provides low-flow ECCO2R using a single, 15.5 French dual-lumen catheter
 inserted percutaneously in the femoral or jugular vein. Low-flow ECCO2R offers an alternative
 or supplement to invasive mechanical ventilation (MV) for patients suffering from acute,
 reversible, hypercapnic respiratory failure. In contrast to invasive MV, low-flow ECCO2R
 provides partial ventilatory support independently of the lungs. The rationale for this study
 is that low-flow ECCO2R with the Hemolung RAS can be used to provide supplemental CO2 removal
 in COPD patients experiencing acute hypercapnic respiratory failure to either avoid or reduce
 time on invasive MV. In this patient population, avoidance or reduced time on invasive MV may
 have significant clinical benefit in reducing the many complications associated with invasive
 MV. The major complication risks of low-flow ECCO2R are associated with central venous
 catheterization and the need for anticoagulation during treatment. This study is designed to
 evaluate the safety and efficacy of Hemolung RAS plus standard-of-care as compared to
 standard-of-care alone.
Inclusion Criteria:

 1. Age ≥ 40 years

 2. Confirmed diagnosis of underlying COPD or ACOS (Asthma-COPD Overlap Syndrome)

 3. Experiencing acute hypercapnic respiratory failure

 4. Informed consent from patient or legally authorized representative

 5. Meets one of the three following criteria:

 1. Is at high risk of requiring intubation and invasive mechanical ventilation (MV)
 after at least one hour on NIV due to one or more of the following:

 -  Respiratory acidosis (arterial pH <= 7.25) despite NIV

 -  Worsening hypercapnia or respiratory acidosis relative to baseline blood
 gases

 -  No improvement in PaCO2 relative to baseline blood gases and presence of
 moderate or severe dyspnea

 -  Presence of tachypnea > 30 breaths per minute

 -  Intolerance of NIV with failure to improve or worsening acidosis, dyspnea or
 work of breathing

 *OR*

 2. After starting NIV with a baseline arterial pH ≤ 7.25, shows signs of progressive
 clinical decompensation manifested by decreased mental capacity, inability to
 tolerate NIV, or increased or decreased respiratory rate in setting of worsened
 or unchanged acidosis.

 *OR*

 3. Currently intubated and receiving Invasive MV, meeting both of the following:

 -  Intubated for ≤ 5 days (from intubation to time of consent), AND

 -  Has failed a spontaneous breathing trial OR is deemed not suitable for a
 spontaneous breathing trial (SBT) OR is deemed not suitable for extubation

 Exclusion Criteria:

 1. DNR/DNI order

 2. Hemodynamic instability (mean arterial pressure < 60 mmHg) despite infusion of
 vasoactive drugs

 3. Acute coronary syndrome

 4. Current presence of severe pulmonary edema due to Congestive Heart Failure

 5. PaO2/FiO2 < 120 mmHg on PEEP >/= 5 cmH2O

 6. Presence of bleeding diathesis or other contraindication to anticoagulation therapy

 7. Platelet count >= 100,000/mm3 not requiring daily transfusions to maintain platelet
 count above 100,000/mm3 at time of screening

 8. Hemoglobin >= 7.0 gm% not requiring daily transfusions to maintain hemoglobin count
 above 7.0 gm% at time of screening, and no active major bleeding

 9. Unable to protect airway (e.g. unable to generate cough or clear secretions) or
 significant weakness or paralysis of respiratory muscles due to causes unrelated to
 acute exacerbation of COPD

 10. Cerebrovascular accident, intracranial bleed, head injury or other neurological
 disorder likely to adversely affect ventilation or airway protection.

 11. Hypersensitivity to heparin or history of previous heparin-induced thrombocytopenia
 (HIT Type II)

 12. Presence of a significant pneumothorax or bronchopleural fistula

 13. Current uncontrolled, major psychiatric disorder

 14. Current participation in any other interventional clinical study

 15. Pregnant women (women of child bearing potential require a pregnancy test)

 16. Neutropenic (absolute neutrophil count < 1,00mm3, not transient) related to the
 presence or treatment of a malignancy; recent bone marrow transplant (within prior 8
 months); current, uncontrolled AIDS.

 17. Fulminant liver failure

 18. Known vascular abnormality or condition which could complicate or prevent successful
 Hemolung Catheter insertion

 19. Terminal patients not expected to survive current hospitalization

 20. Requiring continuous home ventilation via a tracheostomyy

 21. Any disease or condition that, in the judgment of the investigator, either places the
 subject at undue risk of complications from the Hemolung RAS device, or may reduce the
 subject's likelihood of benefitting from therapy with the Hemolung RASr