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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Lung Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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NIOV Ventilator

Breathe NIOV Ventilator under various volume augmentation settings

Group Type EXPERIMENTAL

Breathe NIOV Ventilator

Intervention Type DEVICE

Portable, non invasive open ventilation system

Interventions

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Breathe NIOV Ventilator

Portable, non invasive open ventilation system

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No