In-exsufflator Cough Assist Device in Patients With Symptomatic Bronchiectasis

Bronchiectasis is characterized by airway dilatation with the potential to cause devastating
illness, including repeated respiratory infections requiring antibiotics, disabling
productive, mucopurulent cough, shortness of breath and occasional hemoptysis. The damaged
and dilated airways lead to persisting bacterial infection of the bronchi and bronchioles,
causing inflammation and retained secretions, which in turn may further damage the airways.
Patients typically suffer from frequent, severe and refractory episodes of bacterial
bronchitis, often requiring hospitalization and prolonged courses of antibiotics. The
pathophysiology of bronchiectasis involves the retention of viscid, tenacious inflammatory
secretions and microbes leading to a "vicious cycle" of airway obstruction, destruction and
recurrent infection with further compromise of the mucociliary clearance host defense
apparatus. It has been widely proposed and recommended that methods of enhancing clearance of
airway secretions should be an integral component of the care of patients with
bronchiectasis. Despite these recommendations and a sound pathophysiologic plausibility given
the central role retention of secretions plays in the disease, the effectiveness of
interventions targeted toward enhancing bronchopulmonary hygiene has not been systematically
studied. It is also not known whether the ability to generate an adequate cough would predict
which patient will benefit from these interventions.

The mechanical in-exsufflator device assists patients in clearing retained secretions by
augmenting the expiratory flow and force of the patient's cough with the addition of a cycle
of positive and negative inspiratory pressure. An effective cough mechanism is actually an
important and beneficial host defense which aids in mucus clearance along with the
mucociliary apparatus. We hypothesize that daily, regular use of the in-exsufflator device
will lead to a reduction in acute bronchiectasis exacerbations- a clinically meaningful
endpoint- with other possible beneficial outcomes including improved pulmonary function,
improved health-related quality of life and decreased health care costs.

Despite the lack of rigorous, well-designed studies supporting the role and most effective
mode of bronchial hygiene physiotherapy in patients with bronchiectasis, many Pulmonologists
recommend the flutter valve device as the generally accepted "standard of care" at this time
due to its relative non-invasiveness, ease of use and high level of patient acceptability.
The flutter valve is a simple, hand-held, pipe-like device which helps loosen secretions by
providing an expiratory low-pressure vibratory pulse to the patient's airway when used. This
study will provide a comparison of the clinical efficacy of these mechanical chest
physiotherapy devices in the setting of bronchiectasis.

Inclusion Criteria:

- Chest CT scan confirmation of bronchiectasis

- At least two exacerbations in the preceding 12 months requiring antibiotics

Exclusion Criteria:

- Cystic fibrosis

- Bullous emphysema

- History of spontaneous pneumothorax

- History of massive hemoptysis: greater than 200 cc in a 24 hour period

- Lung resection surgery in the past 6 months

- Use of the mechanical cough in-exsufflator in the prior 3 months

- Inability to speak and read English

- Inability to demonstrate proper use of the cough-assist or flutter device

- Unable to provide informed consent