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In-home Evaluation of a Noninvasive Open Ventilation System in Patients With Severe Respiratory Insufficiency

NCT01347931 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-10-11

Study results available
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Summary

The Breathe NIOV™ System will reduce the work of breathing in subjects with chronic respiratory insufficiency who require long-term oxygen therapy (LTOT). The Breathe system will accomplish this by providing oxygen under pressure and augmenting the subject's spontaneous tidal volumes. The combination of efficient oxygen delivery, assisted ventilation, and a comfortable low-profile device, will result in a mean improvement in perceived well-being and ability to perform ADLs, as measured by patient-reported outcome (PRO) instruments.

Conditions

  • Pulmonary Disease, Chronic Obstructive
  • Airflow Obstruction, Chronic
  • Chronic Obstructive Airway Disease
  • Chronic Obstructive Lung Disease

Interventions

DEVICE

NIOV System

Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.

DEVICE

Standard Oxygen Cannula

Supplemental oxygen via a standard oxygen cannula connected to a portable oxygen cylinder

Sponsors & Collaborators

  • Breathe Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Brian W Carlin, MD · West Penn Allegheny Health System

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-03-31
Completion
2012-03-31

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 NCT01347931 on ClinicalTrials.gov