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

Not Applicable

Completed

• Conditions: Chronic Obstructive Lung Disease
• Interventions: Device: Breathe NIOV Ventilator

• Registration Number: NCT01596023
• Lead Sponsor: Breathe Technologies, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-14
• Last Update Posted: 2014-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NIOV Ventilator	Breathe NIOV Ventilator	Breathe NIOV Ventilator under various volume augmentation settings

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States