Summary

for people ages 22 years and up (full criteria)
at Sacramento, California and other locations
study started
estimated completion
Brian Morrissey

Description

Summary

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.

Official Title

A Prospective, Multi-Center, Randomized, Controlled, Pivotal Trial to Validate the Safety and Efficacy of the Hemolung® Respiratory Assist System for COPD Patients Experiencing an Acute Exacerbation Requiring Ventilatory Support

Details

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.

Keywords

Acute Exacerbation of COPD Hemolung Respiratory Assist System Invasive mechanical ventilation

Eligibility

You can join if…

Open to people ages 22 years and up

  1. Age ≥ 22 years
  2. Confirmed diagnosis of underlying COPD (based on prior spirometry or approved screening procedure) or ACOS (Asthma-COPD Overlap Syndrome) based on prior spirometry or approved screening procedure.
  3. Diagnosed as experiencing an acute exacerbation of COPD
  4. Subject has been receiving standard of care treatment for an acute exacerbation of COPD, including treatment with bronchodilators, corticosteroids, antibiotics, and controlled oxygen therapy.
  5. Able to generate adequate cough and control of secretions
  6. Minimum platelet count of 100,000/mm3 (and not requiring daily transfusions to maintain platelet count above 100,000/mm3) at time of screening.
  7. Minimum hemoglobin of 7.0 gm %, no active major bleeding (and not requiring daily transfusions to maintain hemoglobin count above 7.0 gm%) at time of screening.
  8. Informed consent from patient or legally authorized representative
  9. Meets one of the 2 following sets of population stratification criteria:
  10. (Stratum 1) Has required noninvasive ventilation (NIV) for ≤ 4 days, and
  11. 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

  1. 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.
  2. (Stratum 2) Meets ALL of the following criteria:

-Has required intubation and invasive MV due to acute respiratory failure for ≤ 4 days, either immediately upon presentation or after having failed NIV

-PaCO2 ≥ 50 mmHg prior to intubation

  • Has met criteria for weaning readiness
  • Has failed first spontaneous breathing trial due to increased dyspnea, rate of breathing, work of breathing, and/or dynamic hyperinflation (i.e. reasons associated with hypercapnia)
  • Able to protect airway

You CAN'T join if...

  1. DNR/DNI order
  2. Presence of acute, uncontrolled arrhythmia
  3. Hemodynamic instability (mean arterial pressure < 60 mmHg) despite infusion of vasoactive drugs
  4. Acute coronary syndrome
  5. Acute exacerbation is due primarily to congestive heart failure
  6. PaO2/FiO2 < 120 mmHg on PEEP >/= 5 cmH2O
  7. Current intubation (Stratum 2), or likelihood of intubation (Stratum 1), or will occur, greater than 24 hours but less than 72 hours after prior extubation
  8. Presence of bleeding diathesis or other contraindication to anticoagulation therapy
  9. 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; or receiving long-term (>3 months) high dose immunosuppressants within the last 6 months.
  17. . Presence of severe (acute or chronic) renal failure defined as requiring any form of dialysis.
  18. . Severe liver insufficiency (Child-Pugh scores >7) or INR > 1.6 suspected to be related to liver disease (liver associated coagulopathy)
  19. . Diagnosis of acute pulmonary embolism during current ICU admission
  20. . Known vascular abnormality or unavailable vascular access which could complicate or prevent successful Hemolung Catheter insertion
  21. . Terminal patients not expected to survive current hospitalization
  22. . Ventilated via tracheotomy
  23. . Presence or history of clinically significant disease or other foreseeable risk that outweighs the potential, in the judgement of the investigator

Locations

  • UC Davis Medical Group accepting new patients
    Sacramento California 95817 United States
  • University of Texas Southwestern Medical Center accepting new patients
    Dallas Texas 75390 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alung Technologies
Links
Sign up for this study
ID
NCT03255057
Study Type
Interventional
Last Updated