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

This study has been completed.
Sponsor:
Collaborator:
Tufts Medical Center
Information provided by (Responsible Party):
Breathe Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01596023
First received: May 8, 2012
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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 Intervention
Chronic Obstructive Lung Disease
Device: Breathe NIOV Ventilator

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Evaluation of Effect of Breathe Ventilation System on Work of Breathing in COPD Patients

Resource links provided by NLM:


Further study details as provided by Breathe Technologies, Inc.:

Primary Outcome Measures:
  • Pressure time product of the diaphragm (PTPdi) during use of the Breathe Ventilation System [ Time Frame: 10 min ] [ Designated as safety issue: No ]
    Calculated using the area of the transdiaphragmatic pressure for the duration of inspiration


Secondary Outcome Measures:
  • Changes in PTP of the esophagus (PTPes), PTP per minute (PTPdi/min and PTPes/min [ Time Frame: 10 Min ] [ Designated as safety issue: No ]
    Changes in PTP of the esophagus (PTPes), PTP per minute (PTPdi/min and PTPes/min)


Enrollment: 14
Study Start Date: May 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NIOV Ventilator
Breathe NIOV Ventilator under various volume augmentation settings
Device: Breathe NIOV Ventilator
Portable, non invasive open ventilation system

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01596023

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

No publications provided

Responsible Party: Breathe Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01596023     History of Changes
Other Study ID Numbers: CP-00-0033
Study First Received: May 8, 2012
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Breathe Technologies, Inc.:
COPD

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

ClinicalTrials.gov processed this record on October 29, 2014