Background: For patients with chronic obstructive pulmonary disease (COPD), an increase in exercise tolerance and ability to perform activities of daily living (ADLs) can mean an improved quality of life with fewer exacerbations and lower health care expenses. We evaluated a wearable, noninvasive open ventilation (NIOV) system designed to enhance exercise capacity and increase mobility. Methods:Patients with stable, oxygen-dependent COPD were recruited for this prospective, open-label, crossover study. Inclusion criteria included supplemental oxygen use, elevated dyspnea score, and the ability to perform ADLs. Patients performed a selected ADL for as long as tolerable while using standard oxygen therapy. Following a rest period, the same ADL was repeated using the NIOV system. ADL endurance time, oxyhemoglobin saturation measured by pulse oximeter ( SpO2), dyspnea, fatigue, and discomfort scores were recorded. Results:Thirty patients were enrolled and 29 patients completed the study. Mean ADL endurance increased by 85% (13.4 vs. 7.2 min) using NIOV compared with oxygen therapy (p<0.0001). Mean SpO2 was significantly higher during ADLs using NIOV versus oxygen therapy (p<0.0001). Median dyspnea, fatigue, and discomfort scores were significantly lower using NIOV during ADLs compared to oxygen therapy (p<0.01). No device-related adverse events were observed. Conclusions: This study demonstrated that a novel, portable noninvasive open ventilation system can improve ADL performance in the home setting. Compared to standard oxygen therapy, the NIOV system provided statistically and clinically significant increases in ADL endurance time and oxygenation, while decreasing dyspnea, fatigue, and discomfort. The NIOV system appears to offer a practical option for increasing activity and exercise tolerance in oxygen-dependent patients with COPD.
RCT Entities:
Background: For patients with chronic obstructive pulmonary disease (COPD), an increase in exercise tolerance and ability to perform activities of daily living (ADLs) can mean an improved quality of life with fewer exacerbations and lower health care expenses. We evaluated a wearable, noninvasive open ventilation (NIOV) system designed to enhance exercise capacity and increase mobility. Methods:Patients with stable, oxygen-dependent COPD were recruited for this prospective, open-label, crossover study. Inclusion criteria included supplemental oxygen use, elevated dyspnea score, and the ability to perform ADLs. Patients performed a selected ADL for as long as tolerable while using standard oxygen therapy. Following a rest period, the same ADL was repeated using the NIOV system. ADL endurance time, oxyhemoglobin saturation measured by pulse oximeter ( SpO2), dyspnea, fatigue, and discomfort scores were recorded. Results: Thirty patients were enrolled and 29 patients completed the study. Mean ADL endurance increased by 85% (13.4 vs. 7.2 min) using NIOV compared with oxygen therapy (p<0.0001). Mean SpO2 was significantly higher during ADLs using NIOV versus oxygen therapy (p<0.0001). Median dyspnea, fatigue, and discomfort scores were significantly lower using NIOV during ADLs compared to oxygen therapy (p<0.01). No device-related adverse events were observed. Conclusions: This study demonstrated that a novel, portable noninvasive open ventilation system can improve ADL performance in the home setting. Compared to standard oxygen therapy, the NIOV system provided statistically and clinically significant increases in ADL endurance time and oxygenation, while decreasing dyspnea, fatigue, and discomfort. The NIOV system appears to offer a practical option for increasing activity and exercise tolerance in oxygen-dependent patients with COPD.
Authors: Gregory Snell; Felix J F Herth; Peter Hopkins; Kimberley M Baker; Christian Witt; Mark H Gotfried; Arschang Valipour; Manfred Wagner; Franz Stanzel; Jim J Egan; Steven Kesten; Armin Ernst Journal: Eur Respir J Date: 2011-11-10 Impact factor: 16.671
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