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

Study Overview
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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.

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

Conditions
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Chronic Obstructive Lung Disease

Intervention / Treatment
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* Device: Breathe NIOV Ventilator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD