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

NCT ID: NCT03255057

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-18
• Study Completion Date: 2022-08-17

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.

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.

Conditions

Acute Exacerbation of COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

Hemolung Respiratory Assist System

Intervention Type: DEVICE

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.

Invasive mechanical ventilation

Intervention Type: DEVICE

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.

SOC IMV

Standard-of-care (SOC) invasive mechanical ventilation (IMV) alone

Group Type: ACTIVE_COMPARATOR

Invasive mechanical ventilation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Low-flow extracorporeal carbon dioxide removal; ECCO2R; Hemolung RAS; Hemolung; Respiratory dialysis; Lung dialysis

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alung Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas Hill, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts University Medical Center

Locations

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

Rhode Island Hospital

Providence, Rhode Island, United States

UT Erlanger

Chattanooga, Tennessee, United States

Memphis VA Medical Center

Memphis, Tennessee, United States

UT McGovern Medical School Memorial Hermann

Houston, Texas, United States

Baylor Scott and White Memorial Hospital

Temple, Texas, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Inova Health Care Services

Falls Church, Virginia, United States

Countries

United States

References

Burki NK, Mani RK, Herth FJF, Schmidt W, Teschler H, Bonin F, Becker H, Randerath WJ, Stieglitz S, Hagmeyer L, Priegnitz C, Pfeifer M, Blaas SH, Putensen C, Theuerkauf N, Quintel M, Moerer O. A novel extracorporeal CO(2) removal system: results of a pilot study of hypercapnic respiratory failure in patients with COPD. Chest. 2013 Mar;143(3):678-686. doi: 10.1378/chest.12-0228.

Reference Type: BACKGROUND

PMID: 23460154 (View on PubMed)

Duggal A, Conrad SA, Barrett NA, Saad M, Cheema T, Pannu S, Romero RS, Brochard L, Nava S, Ranieri VM, May A, Brodie D, Hill NS; VENT-AVOID Investigators. Extracorporeal Carbon Dioxide Removal to Avoid Invasive Ventilation During Exacerbations of Chronic Obstructive Pulmonary Disease: VENT-AVOID Trial - A Randomized Clinical Trial. Am J Respir Crit Care Med. 2024 Mar 1;209(5):529-542. doi: 10.1164/rccm.202311-2060OC.

Reference Type: DERIVED

PMID: 38261630 (View on PubMed)

Stokes JW, Gannon WD, Rice TW. Extracorporeal Carbon Dioxide Removal or Extracorporeal Membrane Oxygenation: Why Should We Care? Crit Care Med. 2021 May 1;49(5):e546-e547. doi: 10.1097/CCM.0000000000004844. No abstract available.

Reference Type: DERIVED

PMID: 33854019 (View on PubMed)

Other Identifiers

HL-CA-5000

Identifier Type: -

Identifier Source: org_study_id