Clinical trial NCT03437811: Airway Clearance System (K031876) Phase IV Device Efficacy
Official title: Efficacy of Med Systems' Electro Flo Percussor Model 5000, Airway Clearance System, for Pulmonary Clearance of Secretions.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis, Pulmonary
Keywords: airway clearance system
cystic fibrosis
lung secretion clearance
Lead sponsor: Mack Biotech, Corp.
Sponsor class: INDUSTRY
First posted: 2018-02-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 to 55 years of age, male or female.non-smokers

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage change of oxygen levels in the blood (pulse oximetry).
timeFrame: Change from baseline up to 3.5 hours.
Secondary outcomes:
measure: Percentage change of lung function
timeFrame: Change from baseline up to 3.5 hours
Other outcomes:
Locations:
city: San Diego
country: United States
facility: MED Systems, Inc.
state: California
Study officials:
affiliation: Mack Biotech, Corp.
name: Leigh J Mack, MD, PhD, CPI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Main E, Prasad A, Schans C. Conventional chest physiotherapy compared to other airway clearance techniques for cystic fibrosis. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD002011. doi: 10.1002/14651858.CD002011.pub2.
citation: Oermann CM, Sockrider MM, Giles D, Sontag MK, Accurso FJ, Castile RG. Comparison of high-frequency chest wall oscillation and oscillating positive expiratory pressure in the home management of cystic fibrosis: a pilot study. Pediatr Pulmonol. 2001 Nov;32(5):372-7. doi: 10.1002/ppul.1146.