Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    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
Previous Study | Return to List | Next Study

Extracorporeal CO2 Removal With the Hemolung RAS for Mechanical Ventilation Avoidance During Acute Exacerbation of COPD (VENT-AVOID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03255057
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Alung Technologies

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Exacerbation of COPD Device: Hemolung Respiratory Assist System Device: Invasive mechanical ventilation Not Applicable

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, multi-center, randomized, controlled, two-arm, open-label, adaptive, two-strata, pivotal trial
Masking: Single (Outcomes Assessor)
Masking Description: Due to the nature of the interventional device and treatment, the study participants, care providers, and investigators will not be masked. However, an independent Clinical Endpoint Committee will be masked for adjudication of the primary endpoint and serious adverse events. An independent Data and Safety Monitoring Board will make study continuation recommendations based on the statistical analysis plan and the overall safety and efficacy endpoints without masking.
Primary Purpose: Treatment
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
Actual Study Start Date : February 18, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Hemolung plus SOC IMV
Low-flow ECCO2R with the Hemolung Respiratory Assist System as an alternative or adjunct to standard-of-care (SOC) invasive mechanical ventilation (IMV)
Device: Hemolung Respiratory Assist System
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.
Other Names:
  • Low-flow extracorporeal carbon dioxide removal
  • ECCO2R
  • Hemolung RAS
  • Hemolung
  • Respiratory dialysis
  • Lung dialysis

Device: Invasive mechanical ventilation
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.

Active Comparator: SOC IMV
Standard-of-care (SOC) invasive mechanical ventilation (IMV) alone
Device: Invasive mechanical ventilation
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.




Primary Outcome Measures :
  1. The amount of time in the first five days following randomization that a patient is free of Invasive MV and alive [ Time Frame: 5 days ]
    Statistically analyzed as Ventilator-Free Days during the 5 days from randomization (VFD-5)


Secondary Outcome Measures :
  1. Physiologic benefit [ Time Frame: Time to extubation from first intubation up to 60 days from randomization ]
    Based on blood gases and concomitant ventilation parameters

  2. Avoidance of intubation [ Time Frame: Within 60 days from randomization ]
    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.

  3. Ability to communicate by speaking [ Time Frame: Randomization to end of treatment or 14 days, whichever is sooner ]
    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

  4. Ability to eat and drink orally [ Time Frame: Randomization to end of treatment or 14 days, whichever is sooner ]
    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

  5. ICU Mobility [ Time Frame: Randomization to end of treatment or 14 days, whichever is sooner ]
    Ability of subject to mobilize in bed and out of bed while in Intensive Care as assessed using ICU Mobility Score (IMS)

  6. Daily dose of sedatives, analgesics, and paralytics while in ICU [ Time Frame: From randomization to ICU discharge up to 60 days from randomization ]
    A qualify of life measure for subjects while in ICU measured by reported concomitant medications while in ICU.

  7. Incidence of new tracheotomies [ Time Frame: Within 60 days from randomization ]
    Incidence of new tracheotomies

  8. Adverse events [ Time Frame: Within 60 days from randomization ]
    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)

  9. All-cause in-hospital mortality [ Time Frame: Within 60 days from randomization ]
    Subject death from any cause while still admitted to hospital for the acute exacerbation for which they were enrolled in the study.

  10. All-cause (health-related) mortality at 60 days from randomization [ Time Frame: Within 60 days from randomization ]
    Incidence of health-related deaths at 60 days from randomization, regardless of subject location at time of death.

  11. Incidence of failed extubations [ Time Frame: Within 60 days from randomization ]
    Incidence of re-intubation within 48 hours of extubation for original exacerbation


Other Outcome Measures:
  1. Time to ICU discharge [ Time Frame: From ICU admission to discharge up to 60 days from randomization ]
    Time from ICU admission to ICU discharge for initial exacerbation for which the subject was enrolled for subjects surviving to discharge

  2. Time to hospital discharge [ Time Frame: From hospital admission to discharge up to 60 days from randomization ]
    Time from hospital admission to hospital discharge for initial exacerbation for which the subject was enrolled for subjects surviving to discharge

  3. Time on ventilatory support [ Time Frame: Randomization to end of Hemolung an Invasive MV for initial exacerbation up to 60 days from randomization ]
    Total time on Hemolung and/or Invasive MV support for initial exacerbation

  4. VFD-30 [ Time Frame: Randomization to Day 30 ]
    Ventilator-free days from randomization to 30 days from randomization

  5. SOFA Score [ Time Frame: From randomization to 24 hours after end of investigational treatment (Investigational Arm) or first extubation (Control Arm) up to a maximum of 14 days ]
    Sequential Organ Failure Assessment Score from randomization to 24 hours after end of treatment

  6. Dyspnea [ Time Frame: From randomization to 24 hours after end of investigational treatment (Investigational Arm) or first extubation (Control Arm) up to a maximum of 14 days ]
    A quality of life measure for subjects while in ICU measured with a Visual Analog Score

  7. ICU Delirium [ Time Frame: From randomization to 24 hours after end of investigational treatment (Investigational Arm) or first extubation (Control Arm) up to a maximum of 14 days ]
    A quality of life measure for subjects while in ICU measured with the Confusion Assessment Measure for ICU (CAM-ICU) score

  8. Incidence of DNI/DNR/Comfort care requests post-randomization [ Time Frame: From randomization to 60 days from randomizaiton ]
    Incidence of DNI/DNR/Comfort care requests post-randomization

  9. Incidence of hospital readmissions [ Time Frame: From randomization to 60 days from randomizaiton ]
    Number of new hospital admissions after hospital discharge for original exacerbation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 40 years
  2. Confirmed diagnosis of underlying COPD or ACOS (Asthma-COPD Overlap Syndrome)
  3. Experiencing acute hypercapnic respiratory failure
  4. Informed consent from patient or legally authorized representative
  5. 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

Exclusion Criteria:

  1. DNR/DNI order
  2. Hemodynamic instability (mean arterial pressure < 60 mmHg) despite infusion of vasoactive drugs
  3. Acute coronary syndrome
  4. Current presence of severe pulmonary edema due to Congestive Heart Failure
  5. PaO2/FiO2 < 120 mmHg on PEEP >/= 5 cmH2O
  6. Presence of bleeding diathesis or other contraindication to anticoagulation therapy
  7. Platelet count >= 100,000/mm3 not requiring daily transfusions to maintain platelet count above 100,000/mm3 at time of screening
  8. 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
  9. 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
  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.
  17. Fulminant liver failure
  18. Known vascular abnormality or condition which could complicate or prevent successful Hemolung Catheter insertion
  19. Terminal patients not expected to survive current hospitalization
  20. Requiring continuous home ventilation via a tracheostomyy
  21. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255057


  Show 32 Study Locations
Sponsors and Collaborators
Alung Technologies
Investigators
Layout table for investigator information
Principal Investigator: Nicholas Hill, MD Tufts University Medical Center

Publications:
Layout table for additonal information
Responsible Party: Alung Technologies
ClinicalTrials.gov Identifier: NCT03255057     History of Changes
Other Study ID Numbers: HL-CA-5000
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No