Comparison of Two Positive Expiratory Pressure Devices in Stable COPD Patients
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Registration Number
- NCT02817529
- Lead Sponsor
- Rush University Medical Center
- Brief Summary
Positive expiratory pressure (PEP) therapy is a device aiding airway clearance and secretion mobilization, also prevent the small airway from collapsing. The purpose of this research is to compare two PEP devices (Pulmonica, RC-Cornet) in stable COPD patients. Patients' compliance, satisfaction, 3 months and 6 months lung function test and life quality will be compared.
- Detailed Description
Background : Positive expiratory pressure (PEP) therapy is a type of airway clearance therapy in which the patient exhales through a resistance, which helps to shift the pressure points that aid mobilization of sputum and prevent the lung from collapsing. PEP therapy helps patients reduce the need for ventilatory support, improve hyperinflation and dyspnea. Although PEP devices are used, only a few studies have compared their beneficial effects and preference among COPD patients.
Objective: The purpose of this research is to compare two PEP devices (Pulmonica, RC-Cornet) in stable COPD patients. .
Methods:
A baseline assessment of the patient will be taken at the beginning, three months and the end of six months, including patients' ability to clear secretions via Breathlessness, Cough and Sputum Scale (BCSS), patients' self-reported quality of life via St. George's Respiratory questionnaire (SGRQ) and COPD Assessment Test (CAT) scores, pt's satisfaction with each device, and cardio-pulmonary function via pulmonary function test and six minute walk test in three and six months.
Subsequently, patients will be randomly assigned a PEP device (Pulmonica, RC-Cornet) and given instructions on how to properly use the device including frequency of PEP therapy. Each patient will receive a monthly follow-up call in order to determine adherence and satisfaction with PEP therapy, also BCSS, SGRQ and CAT scores.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Stable COPD patients, younger than 80 years of age, older than 21 years and are willing to participate and give consent to participate
- tracheotomy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The Breathlessness, Cough and Sputum Scale (BCSS) Within 6 months after enrollment
- Secondary Outcome Measures
Name Time Method 6 minutes walk distance 6 months after enrollment St. George's Respiratory questionnaire (SGRQ) scores Within 6 months after enrollment Hospitalization or Emergency room visits within 6 months after enrollment Within 6 months after enrollment Frequency of using OPEP device daily Within 6 months after enrollment COPD Assessment Test (CAT) Within 6 months after enrollment