Research and Evidence

Medical devices are an integral part of clinical practice; the high quality of medicine today is in large measure a direct result of the application of technologies that enhance preventative and interventional medicine.

HFCC Evidence

HFCC is the most extensively studied airway clearance modality currently available. Scores of basic research and clinical trials utilizing a full range of appropriate study designs confirm the safety, efficacy and clinical benefits of the therapy. HFCC is cited in the peer-reviewed medical literature as an effective standard of care therapeutic option. In clinical practice, HFCC is widely prescribed for patients with diverse disorders complicated by secretion clearance dysfunction.

Study designs

Clinical trials of medical devices are far more challenging than drug studies. The physical characteristics of medical equipment often prevent effective use of placebos and single or double-blinding. And unlike simple drug studies, it is rarely possible to recruit large numbers of patients willing to accept randomization and commit to participation in time and effort-demanding long-term studies. Despite such obstacles, the evidence base for HFCC therapy is strong. Results from scores of studies performed at dozens of major medical centers have yielded a consistent and growing body of evidence supporting the clinical, economic and quality of life advantages of HFCC therapy. Study models include:

Modified randomized controlled trials (RCT)
Nonrandomized trials with contemporaneous controls
Nonrandomized trials with historical controls
Cohort studies
Cross-sectional studies
Surveillance (chart reviews, databases, registers, or surveys)
Series of consecutive cases
Single case reports