NCT01596023

Evaluation of Breathe NIOV System on Work of Breathing in Chronic Obstructive Lung Disease Patients

Evaluation of Effect of Breathe Ventilation System on Work of Breathing in COPD Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Breathe Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Breathe Ventilator is a lightweight, wearable ventilator that has received U.S. FDA clearance for use in patients with respiratory difficulty. The investigators believe that the Breathe NIOV system will reduce the work of the diaphragm and breathing by providing added tidal volume and oxygen. This will be a study in 14 patients with severe-to-very severe chronic obstructive lung disease (COPD) to assess their work of breathing while using the NIOV system as measured by esophageal and stomach pressures.

Conditions

• Chronic Obstructive Lung Disease

Interventions

Type	Name	Description
DEVICE	Breathe NIOV Ventilator	Portable, non invasive open ventilation system

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-05-10
• Last updated: 2014-01-15

Locations

1 site across 1 country: United States