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

Breathe Technologies

Status: Completed

Conditions: Chronic Obstructive Lung Disease

Treatments: Device: Breathe NIOV Ventilator

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01596023

CP-00-0033

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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14 participants in 1 patient group

NIOV Ventilator

Experimental group

Description:

Breathe NIOV Ventilator under various volume augmentation settings

Treatment:

Device: Breathe NIOV Ventilator