PURPOSE: Previous studies have shown that the Scandipharm Flutter airway clearance device has increased the ability of cystic fibrosis patients to expectorate mucus. Studies that show the effects of the Flutter on pulmonary function among the pediatric cystic fibrosis patients are limited. Thus, we embarked on a study to assess the device's effectiveness. METHODS: The long-term effect of the Flutter on pulmonary function tests (PFTs) was studied and compared with other airway clearance techniques, such as chest physiotherapy (CPT) and Vital Signs, Inc. 9000 PEP positive expiratory pressure (PEP) therapy for cystic fibrosis patients of five to 17 years of age with mild to moderate disease. Of the 15 patients who qualified, six completed the study. The patients were evaluated using PFTs and a respiratory assessment at the beginning and end of each new therapy. Duration of each therapy was one month. RESULTS: No respiratory assessment parameters changed between the therapies studied. All patients who used the Flutter preferred it over the other two therapies. The patients stated they felt better clinically, were able to expectorate mucus more easily, and felt more in control of their therapies. Paired t-test statistical analysis from the PFT data indicated no significant changes in forced expiratory volume in the first second of expiration (FEV1), forced expiratory flow from 25 percent to 75 percent of the loop (FEF25-75), airway resistance (Raw), or specific airway conductance (sGaw) among the three therapies studied. CONCLUSION: This study has shown no significant change in respiratory assessment parameters or pulmonary function. Further studies involving multicenter trials are warranted to evaluate the effects of the Flutter on pulmonary function.
RCT Entities:
PURPOSE: Previous studies have shown that the Scandipharm Flutter airway clearance device has increased the ability of cystic fibrosispatients to expectorate mucus. Studies that show the effects of the Flutter on pulmonary function among the pediatric cystic fibrosispatients are limited. Thus, we embarked on a study to assess the device's effectiveness. METHODS: The long-term effect of the Flutter on pulmonary function tests (PFTs) was studied and compared with other airway clearance techniques, such as chest physiotherapy (CPT) and Vital Signs, Inc. 9000 PEP positive expiratory pressure (PEP) therapy for cystic fibrosispatients of five to 17 years of age with mild to moderate disease. Of the 15 patients who qualified, six completed the study. The patients were evaluated using PFTs and a respiratory assessment at the beginning and end of each new therapy. Duration of each therapy was one month. RESULTS: No respiratory assessment parameters changed between the therapies studied. All patients who used the Flutter preferred it over the other two therapies. The patients stated they felt better clinically, were able to expectorate mucus more easily, and felt more in control of their therapies. Paired t-test statistical analysis from the PFT data indicated no significant changes in forced expiratory volume in the first second of expiration (FEV1), forced expiratory flow from 25 percent to 75 percent of the loop (FEF25-75), airway resistance (Raw), or specific airway conductance (sGaw) among the three therapies studied. CONCLUSION: This study has shown no significant change in respiratory assessment parameters or pulmonary function. Further studies involving multicenter trials are warranted to evaluate the effects of the Flutter on pulmonary function.
Authors: Ada Clarice Gastaldi; Paolo Paredi; Anjana Talwar; Sally Meah; Peter J Barnes; Omar S Usmani Journal: Medicine (Baltimore) Date: 2015-10 Impact factor: 1.817