The purpose of this study is to evaluate the safety and efficacy of the Hemolung Respiratory Assist System in patients with hypercapnic respiratory failure associated with acute exacerbation of chronic obstructive pulmonary disease (COPD) and a 50% likelihood of failure of noninvasive positive pressure ventilation leading to intubation and mechanical ventilation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Patients meeting the inclusion criteria will be placed on the Hemolung Respiratory Assist System. Patients will be weaned from non-invasive ventilation and then the Hemolung. Hemolung support will be provided for up to 7 days. Follow-up exams will be performed every 15 days until hospital discharge or 30 days from completion of Hemolung therapy, whichever is later.
Artemis Health Institute
Gurgaon, Haryana, India
Frequency of occurrence of serious adverse events while on Hemolung therapy and up to 30 days after cessation of therapy and decannulation.
Time frame: 30 days
Percentage of patients requiring Mechanical Ventilation
Time frame: 7 days
Improvement in patient self assessment of dyspnea using visual analog scale pre- to post-Hemolung therapy.
Time frame: 7 days
Change in Minute Volume (VE) pre- to end-Hemolung therapy
Time frame: 7 days
Number of days in the ICU
Time frame: 30 days
Number of days in the hospital
Time frame: 30 days
Number of days alive and off mechanical ventilation for > 48 hours through the end of Day 30 following completion of Hemolung therapy
Time frame: 30 days
Percentage of patients requiring sedation, and hours of sedation
Time frame: 30 days
Number of days on Non-Invasive Positive Pressure Ventilation (NIPPV)
Time frame: 30 days
For patients requiring Mechanical Ventilation, number of days on Mechanical Ventilation
Time frame: 30 days
Duration of weaning time from NIPPV
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Time frame: 7 days
Duration of weaning time from Hemolung therapy
Time frame: 7 days