Extracorporeal CO2 Removal With the Hemolung RAS for Mechanical Ventilation Avoidance During Acute Exacerbation of COPD

Stopped early · Not applicable

Conditions studied: Acute Exacerbation of COPD

In brief

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.

Key facts

Study ID

NCT03255057

Run by

Alung Technologies

People needed

113

Starts

2018-02-18

Expected to finish

2022-08-17

Last updated by the study team

2022-10-14

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 40 years
• Confirmed diagnosis of underlying COPD or ACOS (Asthma-COPD Overlap Syndrome)
• 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) 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*
• 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*
• 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

You may not qualify if…

• DNR/DNI order
• Hemodynamic instability (mean arterial pressure < 60 mmHg) despite infusion of vasoactive drugs
• Acute coronary syndrome
• Current presence of severe pulmonary edema due to Congestive Heart Failure
• PaO2/FiO2 < 120 mmHg on PEEP >/= 5 cmH2O
• Presence of bleeding diathesis or other contraindication to anticoagulation therapy
• Platelet count >= 100,000/mm3 not requiring daily transfusions to maintain platelet count above 100,000/mm3 at time of screening
• 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
• 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 neurological 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 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)
• 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.
• Fulminant liver failure
• Known vascular abnormality or condition which could complicate or prevent successful Hemolung Catheter insertion
• Terminal patients not expected to survive current hospitalization
• Requiring continuous home ventilation via a tracheostomyy
• 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

Where it is running

• UC Davis Medical Group — Sacramento, California, United States
• Denver Health Medical Center — Denver, Colorado, United States
• Christiana Care Health System — Newark, Delaware, United States
• University of Florida - Health Shands — Gainesville, Florida, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• WellStar Kennestone Regional Medical Center — Marietta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Lexington VA Healthcare — Lexington, Kentucky, United States
• University of Louisville — Louisville, Kentucky, United States
• LSU Health Shreveport — Shreveport, Louisiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Spectrum Health Hospitals — Grand Rapids, Michigan, United States
• Minneapolis Heart — Minneapolis, Minnesota, United States
• Rutgers-Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
• Albany Medical Center — Albany, New York, United States
• Northwell Health — New Hyde Park, New York, United States
• New York Presbyterian Hospital/Columbia University Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Lehigh Valley Health Network — Allentown, Pennsylvania, United States
• Hospital of University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Temple University — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.