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

January 14, 2014 updated by: Breathe Technologies, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is >18 years of age at time of consent.
  2. Subject has diagnosis of severe COPD (GOLD stage III or IV) as demonstrated by a FEV1 < 50% predicted and FEV1/FVC ratio < 70% predicted.
  3. Subject has increased inspiratory muscle work of breathing as evidenced by palpable sternocleidomastoid muscle contraction during inspiration

Exclusion Criteria:

  1. Subject has acute exacerbation of COPD - within 1 week of acute hospitalization
  2. Subject has respiratory rate at rest > 28/min
  3. Subject requires > 5 L/min nasal O2/min to maintain O2sat > 90%
  4. Subject has severe dyspnea at rest
  5. Subject has swallowing disorders or chronic aspiration, prior esophageal surgery, or any other condition that would place the subject at risk during balloon placement.
  6. Subject has history of pneumothorax secondary to lung bullae.
  7. Subject is too cognitively impaired to give subjective ratings for visual analog scale
  8. Subject has sensitivity or an allergy to lidocaine
  9. Subject has known history of oxygen intolerance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NIOV Ventilator
Breathe NIOV Ventilator under various volume augmentation settings
Device: Breathe NIOV Ventilator
Portable, non invasive open ventilation system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure time product of the diaphragm (PTPdi) during use of the Breathe Ventilation System
Time Frame: 10 min
Calculated using the area of the transdiaphragmatic pressure for the duration of inspiration
10 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in PTP of the esophagus (PTPes), PTP per minute (PTPdi/min and PTPes/min
Time Frame: 10 Min
Changes in PTP of the esophagus (PTPes), PTP per minute (PTPdi/min and PTPes/min)
10 Min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Breathe Technologies, Inc.

Collaborators

Tufts Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 8, 2012

First Submitted That Met QC Criteria

May 9, 2012

First Posted (Estimate)

May 10, 2012

Study Record Updates

Last Update Posted (Estimate)

January 15, 2014

Last Update Submitted That Met QC Criteria

January 14, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-00-0033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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