Ensayos clínicos

Inclusion Criteria:

• Age ≥ 40 years.
• Diagnosis of COPD based on previous documented diagnosis of COPD (GOLD Grades 1-4), or ACOS (Asthma-COPD Overlap Syndrome), supported with spirometry (FEV1/FVC < 0.70), as defined by GOLD Criteria.
• Experiencing acute hypercapnic respiratory failure.
• Informed consent from patient or legally authorized representative.
• Meets one of the three following criteria:
• 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, or venous pH ≤ 7.22) despite NIV, worsening or not improving;
  • Worsening hypercapnia or respiratory acidosis relative to baseline blood gases;
  • No improvement in PaCO2 (or PvCO2) 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.
• NOTE: If a patient is receiving intermittent noninvasive support (i.e., alternating BiPAP/CPAP with high-flow nasal cannula) due to BiPAP/CPAP intolerance, this condition meets the above inclusion criterion if the patient is worsening and at high risk of being intubated; OR
  • After starting NIV with a baseline arterial pH ≤ 7.25 (or venous pH ≤ 7.22), 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
  • Currently intubated and receiving Invasive MV, meeting both of the following:
  • Intubated for ≤ 5 days (to time of consent); AND
  • Has failed an SBT OR is deemed not suitable for an SBT; OR
  • Is deemed not suitable for extubation.

Exclusion Criteria:

• Do-not-intubate (DNI) or do-not-resuscitate (DNR) order.
• Hemodynamic instability (mean arterial pressure < 60 mmHg) requiring more than infusion of low dose vasoactive drugs (for example, norepinephrine > 5 mcg/min, and/or epinephrine > 2.5 mcg/min, and/or phenylephrine > 80 mcg/min).
• Acute coronary syndrome (except “demand” ischemia).
• Current presence of severe pulmonary edema due to Congestive Heart Failure (CHF).
• PaO2/FiO2 < 120 mmHg on PEEP ≥ 5 cmH2O.
• Presence of bleeding diathesis or other contraindication to anticoagulation therapy.
• Minimum platelet count of 100,000/mm^3 not requiring daily transfusions to maintain platelet count above 100,000/mm^3 at time of screening.
• Minimum hemoglobin of 7.0 gm% not requiring daily transfusions to maintain hemoglobin count above 7.0 gm% at time of screening, and no active major bleeding.
• 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.
• Cerebrovascular accident, intracranial bleed, head injury or other neurologic disorder likely to adversely affect ventilation or airway protection
• Hypersensitivity to heparin or history of previous heparin-induced thrombocytopenia (HIT Type II).
• Presence of a significant undrained pneumothorax or bronchopleural fistula.
• Current, uncontrolled, major psychiatric disorder.
• Current participation in any other interventional clinical study.
• Pregnant women (women of child-bearing potential require a pregnancy test; either blood or urine tests are acceptable).
• Neutropenic (absolute neutrophil count < 1,000 mm^3, not transient) related to presence or treatment of a malignancy; recent bone marrow transplant (within prior 8 months); current, uncontrolled AIDS.
• Fulminant liver failure.
• Vascular abnormality or condition that could complicate or prevent successful Hemolung Catheter insertion.
• Terminally ill patients not expected to survive current hospitalization.
• Requiring continuous home ventilation via a tracheostomy.
• 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 RAS.
  • NOTE 1: If the response to any of the above is YES, the subject may NOT be enrolled in the study.
  • NOTE 2: The femoral Catheter is contraindicated for patients with an inferior vena cava filter. These patients may be enrolled in the study only if a jugular Catheter is used.

Eligibility last updated 9/8/21. Questions regarding updates should be directed to the study team contact.