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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 113
- 试验地点
- 32
- 主要终点
- The amount of time in the first five days following randomization that a patient is free of Invasive MV and alive
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
- •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
排除标准
- •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
研究组 & 干预措施
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)
干预措施: Hemolung Respiratory Assist System (Device)
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)
干预措施: Invasive mechanical ventilation (Device)
SOC IMV
Standard-of-care (SOC) invasive mechanical ventilation (IMV) alone
干预措施: Invasive mechanical ventilation (Device)
结局指标
主要结局
The amount of time in the first five days following randomization that a patient is free of Invasive MV and alive
时间窗: 5 days
Statistically analyzed as Ventilator-Free Days during the 5 days from randomization (VFD-5)
次要结局
- Physiologic benefit(Time to extubation from first intubation up to 60 days from randomization)
- Daily dose of sedatives, analgesics, and paralytics while in ICU(From randomization to ICU discharge up to 60 days from randomization)
- All-cause (health-related) mortality at 60 days from randomization(Within 60 days from randomization)
- Avoidance of intubation(Within 60 days from randomization)
- Ability to communicate by speaking(Randomization to end of treatment or 14 days, whichever is sooner)
- Adverse events(Within 60 days from randomization)
- Ability to eat and drink orally(Randomization to end of treatment or 14 days, whichever is sooner)
- ICU Mobility(Randomization to end of treatment or 14 days, whichever is sooner)
- Incidence of new tracheotomies(Within 60 days from randomization)
- All-cause in-hospital mortality(Within 60 days from randomization)
- Incidence of failed extubations(Within 60 days from randomization)