Research Study: VENT AVOID
Condition:
Chronic Obstructive Pulmonary Disease (COPD)
Study Sponsor: ALung Technologies
Study Investigator: Ramiro Saavedra-Romero, MD
Study Contact: Carina Benson
carina.benson@allina.com
612-863-6288
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:

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.
Eligibility Criteria:

  • 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:
    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

Interested in participating in this study?

Reach out to the study contact directly, or fill out this form and we will contact you and assess whether you are an eligible candidate!

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