NCT01021605

Feasibility Study of the Hemolung Respiratory Assist System (Germany)

A Prospective, Non-Randomized Feasibility Study of the Hemolung Respiratory Assist System in Patients With Acute Hypercapnic Respiratory Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (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 (RAS) in patients with hypercapnic respiratory failure.

Detailed description

The objective of the feasibility study is to evaluate the safety and efficacy of the Hemolung RAS in patients with hypercapnic respiratory failure in five groups of patients: Group 1: COPD patients with an acute exacerbation and have a 50% likelihood of failure of noninvasive positive pressure ventilation (NIPPV) leading to intubation and mechanical ventilation Group 2: Patients with hypercapnic respiratory failure on invasive mechanical ventilation who have either: * Failed two or more weaning attempts OR * Failed one or more weaning attempts and do not wish to be invasively mechanically ventilated. Group 3: Patients with hypercapnic respiratory failure on noninvasive positive pressure ventilation who have failed two weaning attempts and do not wish to be invasively mechanically ventilated. Group 4: Patients with hypercapnic respiratory failure who in the view of the treating physician are declining on optimized non-invasive positive pressure ventilation OR demonstrate a complete intolerance of non-invasive positive pressure ventilation for any reason and invasive mechanical ventilation is considered undesirable by the treating physician. Group 5: Patients who are currently invasively mechanically ventilated and in the view of the treating physician would benefit from the application of protective lung ventilation, and in whom this cannot be achieved without significant worsening of respiratory failure.

Conditions

• Hypercapnic Respiratory Failure, COPD, ARDS

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 or invasive ventilation and then the Hemolung RAS. 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: 2009-12-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2009-11-30
• Last updated: 2019-09-30

Locations

7 sites across 1 country: Germany