In-exsufflator Cough Assist Device in Patients With Symptomatic Bronchiectasis

NCT ID: NCT00452114

Last Updated: 2018-09-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2008-05-31

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 Description

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.

Conditions

Bronchiectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Assignment to In-Exsufflator Cough Assist Device

In-Exsufflator Cough Assist Device augments the expiratory flow and force of the patient's cough with the addition of a cycle of positive and negative inspiratory pressure when used daily

Group Type: ACTIVE_COMPARATOR

In-Exsufflator Cough Assist Device

Intervention Type: DEVICE

Assignment to flutter valve device

flutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily

Group Type: ACTIVE_COMPARATOR

Active Comparator: Flutter Valve Device

Intervention Type: DEVICE

Active Comparator

Interventions

In-Exsufflator Cough Assist Device

Intervention Type: DEVICE

Active Comparator: Flutter Valve Device

Active Comparator

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Stephen Krinzman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen J Krinzman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

UMass Memorial Medical Center, Universty Campus

Worcester, Massachusetts, United States

St. Vincent Medical Center

Worcester, Massachusetts, United States

Countries

United States

Other Identifiers

H-11138

Identifier Type: -

Identifier Source: org_study_id