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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
113
Treatment with a medical device called the Hemolung RAS. The Hemolung RAS includes three components: the Hemolung Controller, the Hemolung Cartridge, and the Hemolung Catheter. The intervention is use of the Hemolung RAS to provide partial lung support for acute hypercapnic lung failure by filtering carbon dioxide from venous blood using a central venous catheter through which venous blood is pumped at flows of 350-550 milliliters per minute to and from an external circuit containing a hollow fiber membrane blood gas exchanger (with heparin-coated fibers) integrated with a centrifugal pump.
Lung support for acute lung failure applied with a mechanical ventilation device that uses positive pressure to mechanically inflate the lungs and facilitate exhalation via an endotracheal tube or tracheotomy.
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
The amount of time in the first five days following randomization that a patient is free of Invasive MV and alive
Statistically analyzed as Ventilator-Free Days during the 5 days from randomization (VFD-5)
Time frame: 5 days
Physiologic benefit
Based on blood gases and concomitant ventilation parameters
Time frame: Time to extubation from first intubation up to 60 days from randomization
Avoidance of intubation
Incidence of subjects who did not require intubation at any time during their primary hospital admission for the exacerbation for which they were enrolled in the study.
Time frame: Within 60 days from randomization
Ability to communicate by speaking
Number of days from randomization to end of treatment (end of Invasive MV in Control Arm and end of Hemolung treatment in Investigational Arm) subject is able to communicate by speaking
Time frame: Randomization to end of treatment or 14 days, whichever is sooner
Ability to eat and drink orally
Number of days from randomization to end of treatment (end of Invasive MV in Control Arm and end of Hemolung treatment in Investigational Arm) subject is able to eat and drink orally
Time frame: Randomization to end of treatment or 14 days, whichever is sooner
ICU Mobility
Ability of subject to mobilize in bed and out of bed while in Intensive Care as assessed using ICU Mobility Score (IMS)
Time frame: Randomization to end of treatment or 14 days, whichever is sooner
Daily dose of sedatives, analgesics, and paralytics while in ICU
A qualify of life measure for subjects while in ICU measured by reported concomitant medications while in ICU.
Time frame: From randomization to ICU discharge up to 60 days from randomization
Incidence of new tracheotomies
Incidence of new tracheotomies
Time frame: Within 60 days from randomization
Adverse events
All Serious Adverse Events (SAE) from randomization to 60 days and non-serious adverse events from randomization to ICU discharge or 30 days, whichever is sooner (adjudicated by the Clincal Events Committee)
Time frame: Within 60 days from randomization
All-cause in-hospital mortality
Subject death from any cause while still admitted to hospital for the acute exacerbation for which they were enrolled in the study.
Time frame: Within 60 days from randomization
All-cause (health-related) mortality at 60 days from randomization
Incidence of health-related deaths at 60 days from randomization, regardless of subject location at time of death.
Time frame: Within 60 days from randomization
Incidence of failed extubations
Incidence of re-intubation within 48 hours of extubation for original exacerbation
Time frame: Within 60 days from randomization
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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
...and 22 more locations