NCT00987740

Feasibility Study of the Hemolung Respiratory Assist System

A Prospective, Non-Randomized Feasibility Study of the Hemolung Respiratory Assist System in COPD Patients With Acute Respiratory Failure That Are at a 50% Risk of Failing Non Invasive Ventilation (NIV)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Alung Technologies · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypercapnic Respiratory Failure, COPD

Interventions

Type	Name	Description
DEVICE	Hemolung Respiratory Assist System	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.

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-07-01
• Completion: 2010-08-01
• First posted: 2009-10-01
• Last updated: 2017-08-10

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated device study