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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01596023
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : January 15, 2014
Tufts Medical Center
Information provided by (Responsible Party):
Breathe Technologies, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Lung Disease Device: Breathe NIOV Ventilator Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Evaluation of Effect of Breathe Ventilation System on Work of Breathing in COPD Patients
Study Start Date : May 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01596023

United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Breathe Technologies, Inc.
Tufts Medical Center
Principal Investigator: Nicholas Hill, MD Tufts Medical Center

Responsible Party: Breathe Technologies, Inc. Identifier: NCT01596023     History of Changes
Other Study ID Numbers: CP-00-0033
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: January 15, 2014
Last Verified: January 2014

Keywords provided by Breathe Technologies, Inc.:

Additional relevant MeSH terms:
Lung Diseases
Respiratory Aspiration
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes