Non-invasive Ventilation System in Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) (PRIDE)
|ClinicalTrials.gov Identifier: NCT01355978|
Recruitment Status : Completed
First Posted : May 19, 2011
Results First Posted : October 12, 2016
Last Update Posted : October 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive Airflow Obstruction, Chronic Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease||Device: Noninvasive Open Ventilation System||Not Applicable|
The primary objective of the study was to evaluate the Breathe Technologies Ventilator System with regard to subject acceptability, comfort, and effect on exercise and activities of daily living tolerance.
When using the Breathe Technologies Ventilation System during simulated activities of daily living (ADL), Subjects with moderate-to-severe COPD will be comfortable and report acceptability.
- When using the Breathe Technologies Ventilation System during simulated ADLs, Subjects with moderate-to-severe COPD will experience tolerable dyspnea as measured using the Borg Dyspnea Score (BDS) and a visual analog Comfort Scale (VACS).
- Subjects will prefer using the Breathe Technologies Ventilation System over standard oxygen therapy during exertion and during ADLs after using the ventilator therapy for five days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Acceptability, Comfort, and Exercise Tolerance Using a Non-invasive Ventilation System in Patients With Moderate-to-Severe COPD (PRIDE)|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
Experimental: Noninvasive Open Ventilation System
Portable noninvasive open ventilator & nasal interface.
Device: Noninvasive Open Ventilation System
Noninvasive ventilation system
- Device Tidal Volume [ Time Frame: Periodically over six hours x 5 days ]Evaluate the mean test volume for three activity levels. Subjects completed five consecutive, 6-hour clinic days in which the NIOV system was worn continuously while at rest, during activities of daily living (ADLs).
- Device Preference [ Time Frame: At conclusion of subject's participation (up to two weeks) ]
5-point Likert Scale completed at the end or the 5-day study period
- Preference Scale: 5 = Max preference (Prefer to use the test device), 1 = Min preference (Do not prefer to use the test device)
- Safety and Device-related Adverse Events [ Time Frame: Continuous from Study Day 2 through Study Day 6 ]Any adverse events reported during he study period.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01355978
|United States, California|
|John Muir Health|
|Concord, California, United States, 94520|
|Sharp Memorial Hospital|
|San Diego, California, United States, 92123|
|United States, Utah|
|McKay-Dee Hospital Center|
|Ogden, Utah, United States, 84403|
|Principal Investigator:||Richard Kops, MD||John Muir Health|
|Principal Investigator:||Lynn McCabe, RRT, RCP||Sharp HealthCare|