A Prospective, Non-Randomized Feasibility Study of theHemolung? Respiratory Assist System in COPD Patients with Acute Respiratory Failure that are at a 50% Risk of FailingNon Invasive Ventilation (NIV)

ALung Technologies, Inc.333 East Carson, Suite 517APittsburgh PA 152190 sites10 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sponsor

ALung Technologies, Inc.333 East Carson, Suite 517APittsburgh PA 15219

•\&\#61623; Moderate or severe COPD, as defined by the GOLD criteria
•\&\#61623; Acute exacerbation of COPD (sustained worsening of patient?s condition necessitating a change in regular medication)
•\&\#61623; On non\-invasive positive pressure mechanical ventilation \> 1hour with either:
•o PaCO2 \> 55 mmHg with pH \< 7\.25 OR
•o PaCO2 \> 55 mmHg with \< 5mmHg decrease from baseline and
•pH \< 7\.30
•\&\#61623; Not severely hypoxemic (PaO2/FiO2 \&\#8805; 200 mmHg on PEEP/CPAP
•\&\#8804; 5 cmH2O)
•\&\#61623; Hemodynamically stable (mean arterial pressure \> 65 mmHg
•without vasopressor support)

•\&\#61623; Presence of acute, uncontrolled arrhythmia
•\&\#61623; Acute ischemic heart disease
•\&\#61623; Presence of bleeding diathesis
•\&\#61623; Significant abnormality or weakness/paralysis of respiratory muscles due to a know muscular dystrophy or neurologic disorder
•\&\#61623; Recent (\< 7 days) prolonged (\>24 hrs) use of muscle paralyzing agents
•\&\#61623; Cerebrovascular accident, intracranial bleed, head injury or other neurologic disorder likely to affect ventilation
•\&\#61623; Coma from any cause, or decreased consciousness
•\&\#61623; Hypersensitivity to heparin or previous heparin induced
•thrombocytopenia
•\&\#61623; Recent (\< 6 months) major chest abdominal trauma or surgery

Not specified