Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT03255057
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT03255057
Study Brief:
Protocol Section:
NCT03255057