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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01596023

Enrollment

Registered

2012-05-10

Start date

2012-05-31

Completion date

2013-12-31

Last updated

2014-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Lung Disease

Keywords

COPD

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.

Interventions

DEVICEBreathe NIOV Ventilator

Portable, non invasive open ventilation system

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Pressure time product of the diaphragm (PTPdi) during use of the Breathe Ventilation System	10 min	Calculated using the area of the transdiaphragmatic pressure for the duration of inspiration

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026