Back to resultsEvaluation of Breathe NIOV System on Work of Breathing in Chronic Obstructive Lung Disease Patients
Primary Purpose
Chronic Obstructive Lung Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breathe NIOV Ventilator
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Obstructive Lung Disease focused on measuring COPD
Eligibility Criteria
Inclusion Criteria:
- Subject is >18 years of age at time of consent.
- Subject has diagnosis of severe COPD (GOLD stage III or IV) as demonstrated by a FEV1 < 50% predicted and FEV1/FVC ratio < 70% predicted.
- Subject has increased inspiratory muscle work of breathing as evidenced by palpable sternocleidomastoid muscle contraction during inspiration
Exclusion Criteria:
- Subject has acute exacerbation of COPD - within 1 week of acute hospitalization
- Subject has respiratory rate at rest > 28/min
- Subject requires > 5 L/min nasal O2/min to maintain O2sat > 90%
- Subject has severe dyspnea at rest
- Subject has swallowing disorders or chronic aspiration, prior esophageal surgery, or any other condition that would place the subject at risk during balloon placement.
- Subject has history of pneumothorax secondary to lung bullae.
- Subject is too cognitively impaired to give subjective ratings for visual analog scale
- Subject has sensitivity or an allergy to lidocaine
- Subject has known history of oxygen intolerance.
Sites / Locations
- Tufts Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NIOV Ventilator
Arm Description
Breathe NIOV Ventilator under various volume augmentation settings
Outcomes
Primary Outcome Measures
Pressure time product of the diaphragm (PTPdi) during use of the Breathe Ventilation System
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
Changes in PTP of the esophagus (PTPes), PTP per minute (PTPdi/min and PTPes/min)
Full Information
NCT ID
NCT01596023
First Posted
May 8, 2012
Last Updated
January 14, 2014
Sponsor
Breathe Technologies, Inc.
Collaborators
Tufts Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01596023
Brief Title
Evaluation of Breathe NIOV System on Work of Breathing in Chronic Obstructive Lung Disease Patients
Official Title
Evaluation of Effect of Breathe Ventilation System on Work of Breathing in COPD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Breathe Technologies, Inc.
Collaborators
Tufts Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Lung Disease
Keywords
COPD
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NIOV Ventilator
Arm Type
Experimental
Arm Description
Breathe NIOV Ventilator under various volume augmentation settings
Intervention Type
Device
Intervention Name(s)
Breathe NIOV Ventilator
Intervention Description
Portable, non invasive open ventilation system
Primary Outcome Measure Information:
Title
Pressure time product of the diaphragm (PTPdi) during use of the Breathe Ventilation System
Description
Calculated using the area of the transdiaphragmatic pressure for the duration of inspiration
Time Frame
10 min
Secondary Outcome Measure Information:
Title
Changes in PTP of the esophagus (PTPes), PTP per minute (PTPdi/min and PTPes/min
Description
Changes in PTP of the esophagus (PTPes), PTP per minute (PTPdi/min and PTPes/min)
Time Frame
10 Min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is >18 years of age at time of consent.
Subject has diagnosis of severe COPD (GOLD stage III or IV) as demonstrated by a FEV1 < 50% predicted and FEV1/FVC ratio < 70% predicted.
Subject has increased inspiratory muscle work of breathing as evidenced by palpable sternocleidomastoid muscle contraction during inspiration
Exclusion Criteria:
Subject has acute exacerbation of COPD - within 1 week of acute hospitalization
Subject has respiratory rate at rest > 28/min
Subject requires > 5 L/min nasal O2/min to maintain O2sat > 90%
Subject has severe dyspnea at rest
Subject has swallowing disorders or chronic aspiration, prior esophageal surgery, or any other condition that would place the subject at risk during balloon placement.
Subject has history of pneumothorax secondary to lung bullae.
Subject is too cognitively impaired to give subjective ratings for visual analog scale
Subject has sensitivity or an allergy to lidocaine
Subject has known history of oxygen intolerance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Hill, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Breathe NIOV System on Work of Breathing in Chronic Obstructive Lung Disease Patients
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