Trials / Completed
CompletedNCT01372462
Effects of the Breathe Technologies Ventilation System in Subjects With Chronic Obstructive Pulmonary Disease
A Pilot Study of the Physiologic Effects of Using the Breathe Technologies Noninvasive Open Ventilation System During Constant Work Rate Exercise in Subjects With Chronic Obstructive Pulmonary Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Breathe Technologies, Inc. · Industry
- Sex
- Male
- Age
- 40 Years
- Healthy volunteers
- Accepted
Summary
Pilot study in 15 stable male subjects with severe-to-very severe Chronic Obstructive Pulmonary Disease (COPD) to evaluate the effects of short term use of the Breathe Technologies noninvasive open ventilation (NIOV) system on respiratory mechanics during constant work rate exercise in subjects with severe COPD.
Detailed description
Study was a randomized double-blinded crossover design in which subjects completed a series of exercises at a constant work rate while using 1) Test noninvasive ventilation (NIOV) system powered by compressed air, 2) Test NIOV system powered by 100% oxygen, 3) nasal cannula oxygen, 4) nothing (Control). Subjects were assessed during constant work rate exercise as reflected by exercise duration, isotime oxygenation (SpO2), and isotime dyspnea score (Borg). Exercise sessions took place over 4 visits with each visit lasting approximately 5 hours.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NIOV - Room Air | Noninvasive ventilation with device powered by compressed room air. |
| DEVICE | NIOV - Oxygen | Noninvasive ventilation with device powered by compressed medical (100%) oxygen. |
| DEVICE | Nasal Cannula Oxygen | Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen. |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2012-05-01
- Completion
- 2012-05-01
- First posted
- 2011-06-14
- Last updated
- 2016-10-12
- Results posted
- 2016-10-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01372462. Inclusion in this directory is not an endorsement.