Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452114
Status:
TERMINATED
Last Update Posted:
2018-09-18
First Post:
2007-03-22
Brief Title:
In-exsufflator Cough Assist Device in Patients With Symptomatic Bronchiectasis
Sponsor:
University of Massachusetts Worcester
Organization:
University of Massachusetts Worcester
Study Overview
Official Title:
A Randomized Controlled Study Evaluating the Effectiveness of the Inexsufflator Cough Assist Device in Patients With Symptomatic Bronchiectasis
Status:
TERMINATED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
interim analysis indicates statistical futility for primary outcomes
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 patients airway when used This study will provide a comparison of the clinical efficacy of these mechanical chest physiotherapy devices in the setting of bronchiectasis
The mechanical in-exsufflator device assists patients in clearing retained secretions by augmenting the expiratory flow and force of the patients 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 patients airway when used This study will provide a comparison of the clinical efficacy of these mechanical chest physiotherapy devices in the setting of bronchiectasis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None