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

Chronic Obstructive Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596023
• Other study ID #: CP-00-0033
• Status: Completed
• Phase: N/A
• First received: May 8, 2012
• Last updated: January 14, 2014
• Start date: May 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Breathe Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Obstructive Lung Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Breathe NIOV Ventilator
Portable, non invasive open ventilation system

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Breathe Technologies, Inc.	Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No