Airway Clearance System (K031876) Phase IV Device Efficacy

Study Overview
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Brief Summary
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Phase IV interventional study of adults (18 to 55) having a diagnosis of cystic fibrosis (mild, moderate or severe). The study is completely voluntary and is designed to measure participants use and the effectiveness of the device within the 510K indication of: airway clearance therapy when external manipulation of the thorax. The trial period shall be 21 days and include use of a FDA cleared pulse oximetry monitor (K131111), manual spirometer as well as completion of semi-weekly participant survey.

Detailed Description
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Phase IV interventional study, of participants with cystic fibrosis with mild, moderate or severe conditions, for the efficacy of the Electro Flo Percussor, Model 5000 (K031876), Regulation Number: 21 CFR 868.5665, with current FDA indication of: provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy ( I ) (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the Med Systems Electro Flo Percussor Model 5000 is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.

Official Title
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Efficacy of Med Systems' Electro Flo Percussor Model 5000, Airway Clearance System, for Pulmonary Clearance of Secretions.

Conditions
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Cystic Fibrosis, Pulmonary

Intervention / Treatment
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* Device: Electro Flo Percussor, Model 5000


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously diagnosed with cystic fibrosis (mild, moderate or severe) Prescribed (licensed medical provider) airway clearance device/system for at home, self-treatment for airway clearance Physically able to perform self-treatment or treatment by an at home medical provider Exclusion Criteria: History of tobacco use History of excessive alcohol consumption, more than 2 drinks per day, 10 per week Any other medical condition that would preclude use of an airway clearance device Previously diagnosed with major cardiological disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Treatment<br>Active arm, Electro Flo Percussor, Model 5000 airway clearance system for daily basis as needed (pro re nata). | Device: Electro Flo Percussor, Model 5000<br>* FDA 510K K031876 Regulation Number: 21 CFR 868.5665 Regulation Name: Percussor, Powered-Electric Regulation Class: II Product Code: BY1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change of oxygen levels in the blood (pulse oximetry). | SpO2 will be monitored using the standard pulse oximeter system (K131111). | Change from baseline up to 3.5 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change of lung function | Evaluate expiratory forced vital capacity (FVC) and forced expiratory volume (FEV1) will be monitored with standard spirometer. | Change from baseline up to 3.5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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airway clearance system, cystic fibrosis, lung secretion clearance