Clinical Trial: In-exsufflator Cough Assist Device in Patients With Symptomatic Bronchiectasis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized, Controlled Study Evaluating the Effectiveness of the Inexsufflator Cough Assist Device in Patients With Symptomatic Bronchiectasis

Brief Summary: This study is a randomized, controlled trial examining the effectiveness of the mechanical cough-assist device (in-exsufflator) in promoting the clearance of retained airway secretions in patients with symptomatic bronchiectasis. We hypothesize that this enhanced clearance of airway secretions will lead to a decline in the number of acute exacerbations of bronchiectasis experienced by these patients during the study period, improve health-related quality of life, decrease overall health-care costs and improve pulmonary function.

Detailed Summary:

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, regula
Sponsor: University of Massachusetts, Worcester

Current Primary Outcome:

  • Number of Suppurative Exacerbations Per Patient Per Year [ Time Frame: 12 months ]
  • Number of Hospitalizations and Urgent/Unscheduled Outpatient Visits [ Time Frame: 12 months ]


Original Primary Outcome:

  • Number of Suppurative Exacerbations Per Patient Per Year
  • Number of Hospitalizations and Urgent/Unscheduled Outpatient Visits


Current Secondary Outcome:

  • Quality of Life (St. George's Respiratory Questionnaire, Cough-Specific Quality of Life Questionnaire) [ Time Frame: 12 months ]
  • Pulmonary Function: FEV1 [ Time Frame: 12 months ]
  • Peak Expiratory Cough Flow [ Time Frame: 12 months ]


Original Secondary Outcome:

  • Quality of Life (St. George's Respiratory Questionnaire, Cough-Specific Quality of Life Questionnaire)
  • Pulmonary Function: FEV1
  • Peak Expiratory Cough Flow
  • Cost


Information By: University of Massachusetts, Worcester

Dates:
Date Received: March 22, 2007
Date Started: April 2004
Date Completion:
Last Updated: January 30, 2013
Last Verified: January 2013