Evaluation of Breathe NIOV System on Work of Breathing in Chronic Obstructive Lung Disease Patients
| Status: | Completed |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/1/2014 |
| Start Date: | May 2012 |
| End Date: | June 2013 |
| Contact: | Aarti Grover, MD |
| Email: | agrover@tuftsmedicalcenter.org |
| Phone: | 617-636-6366 |
Evaluation of Effect of Breathe Ventilation System on Work of Breathing in COPD Patients
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.
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.
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.
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