Status:
TERMINATED
Extracorporeal CO2 Removal With the Hemolung RAS for Mechanical Ventilation Avoidance During Acute Exacerbation of COPD
Lead Sponsor:
Alung Technologies
Conditions:
Acute Exacerbation of COPD
Eligibility:
All Genders
40+ years
Phase:
NA
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 ventilatio...
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...
Eligibility Criteria
Inclusion
- 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
- \*OR\*
- 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\*
- 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
- 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
Key Trial Info
Start Date :
February 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2022
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT03255057
Start Date
February 18 2018
End Date
August 17 2022
Last Update
October 14 2022
Active Locations (32)
Enter a location and click search to find clinical trials sorted by distance.
1
UC Davis Medical Group
Sacramento, California, United States, 95817
2
Denver Health Medical Center
Denver, Colorado, United States, 80204
3
Christiana Care Health System
Newark, Delaware, United States, 19718
4
University of Florida - Health Shands
Gainesville, Florida, United States, 32610