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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
15
Noninvasive ventilation with device powered by compressed room air.
Noninvasive ventilation with device powered by compressed medical (100%) oxygen.
Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen.
Harbor-UCLA Medical Center
Torrance, California, United States
Exercise Duration for Constant Work Rate Exercise Tests Under 4 Test Conditions
Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).
Time frame: Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and Nasal Cannula Oxygen.
SpO2 During Constant Workrate Exercise at Isotime
Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).
Time frame: Outcome was measured in each of the Study day 1,2, 3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxyg
Borg Dyspnea Score During Constant Workrate Exercise at Isotime
Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control) at isotime. Borg Dyspnea Score ranges in values from 0 to 10. The lower score represent better outcome. 0 = No breathlessness at all, representing better outcome 10 = Maximum breathlessness, representing worse outcome
Time frame: Outcome was measured in each Study day 1,2,3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and N
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