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

NCT01596023 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2014-01-15

No results posted yet for this study

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

DEVICE

Breathe NIOV Ventilator

Portable, non invasive open ventilation system

Sponsors & Collaborators

  • Tufts Medical Center

    collaborator OTHER

  • Breathe Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Nicholas Hill, MD · Tufts Medical Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01596023 on ClinicalTrials.gov