Evaluation of Breathe NIOV System on Work of Breathing in Chronic Obstructive Lung Disease Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NIOV Ventilator Breathe NIOV Ventilator under various volume augmentation settings |
Device: Breathe NIOV Ventilator
Portable, non invasive open ventilation system
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject is >18 years of age at time of consent.
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Subject has diagnosis of severe COPD (GOLD stage III or IV) as demonstrated by a FEV1 < 50% predicted and FEV1/FVC ratio < 70% predicted.
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Subject has increased inspiratory muscle work of breathing as evidenced by palpable sternocleidomastoid muscle contraction during inspiration
Exclusion Criteria:
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Subject has acute exacerbation of COPD - within 1 week of acute hospitalization
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Subject has respiratory rate at rest > 28/min
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Subject requires > 5 L/min nasal O2/min to maintain O2sat > 90%
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Subject has severe dyspnea at rest
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Subject has swallowing disorders or chronic aspiration, prior esophageal surgery, or any other condition that would place the subject at risk during balloon placement.
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Subject has history of pneumothorax secondary to lung bullae.
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Subject is too cognitively impaired to give subjective ratings for visual analog scale
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Subject has sensitivity or an allergy to lidocaine
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Subject has known history of oxygen intolerance.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tufts Medical Center | Boston | Massachusetts | United States | 02111 |
Sponsors and Collaborators
- Breathe Technologies, Inc.
- Tufts Medical Center
Investigators
- Principal Investigator: Nicholas Hill, MD, Tufts Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CP-00-0033