In-Exsufflator Cough Assist Device in Patients With Symptomatic Bronchiectasis

2014-08-26 22:39:26 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Bronchiectasis

Intervention

In-Exsufflator Cough Assist Device

Location

UMass Memorial Medical Center, Universty Campus
Worcester
Massachusetts
United States
01605

Status

Terminated

Source

University of Massachusetts, Worcester

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-26T22:39:26-0400

Clinical Trials [406 Associated Clinical Trials listed on BioPortfolio]

Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis?

Bronchiectasis is a chronic chest condition which causes a persistent cough and frequent chest infections. One of the main forms of treatment is chest physiotherapy. Physiotherapy is thoug...

Comparison Between Respiratory Therapy With Cough Assist Technique and Usual Respiratory Therapy in Intensive Care Patients Suffering of Neurologic Disorder

The present study aims to compare the efficiency of respiratory therapy with cough assist and the efficiency of usual respiratory therapy in intensive care patients suffering of neurologic...

Bronchiectasis Research Registry

The Bronchiectasis Research Registry is a consolidated database of non-cystic fibrosis (non-CF) Bronchiectasis and Nontuberculosis Mycobacteria (NTM) patients from multiple clinical instit...

Inspiratory Flow and Volumes in Bronchiectatics

Adequate administration of drugs via dry powder inhalers is dependent on adequate inspiratory flow rates and volumes. These vary according to the device being used and its resistance. The ...

Esophageal Motility in Reflux Induced Cough

To determine whether contraction abnormalities in the esophagus plays a role in gastroesophageal reflux induced cough, and thus cough severity in patients with chronic cough.

PubMed Articles [3258 Associated PubMed Articles listed on BioPortfolio]

Validation of the Mandarin Chinese version of the Leicester Cough Questionnaire in bronchiectasis.

The Leicester Cough Questionnaire (LCQ) has been validated for assessing cough-specific health status in bronchiectasis. We translated the LCQ into Mandarin Chinese and investigated its validity, reli...

Arrhythmias in children with ventricular assist devices.

Background: Children with decompensated heart failure are at high risk for arrhythmias, and ventricular assist device placement is becoming a more common treatment strategy. The impact of ventricular ...

Implantation of HeartMate II Left Ventricular Assist Device in a Single-Lung Patient.

The use of mechanical assist devices has been established as an effective therapy for patients with end-stage heart failure. Implantable left ventricular assist devices are becoming more common in the...

Imaging in Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis.

Bronchiectasis is defined as a permanent and progressive dilation of the airways, typically as a result of inflammation, infection, and subsequent repair. It typically presents with chronic cough, sup...

Adult and paediatric cough guidelines: ready for an overhaul?

Cough is one of the most common reasons that patients seek medical attention. Cough guidelines from numerous countries and societies are available to assist the clinician to investigate and manage pat...

Medical and Biotech [MESH] Definitions

Agents that suppress cough. They act centrally on the medullary cough center. EXPECTORANTS, also used in the treatment of cough, act locally.

Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.

Persistent abnormal dilatation of the bronchi.

Removal of a MEDICAL DEVICE from the market due to a problem occurring in the manufacture or distribution of the product.

The shifting in position or location of an INTRAUTERINE DEVICE from its original placement.

More From BioPortfolio on "In-Exsufflator Cough Assist Device in Patients With Symptomatic Bronchiectasis"


Advertisement
 

Relevant Topics

Nutrition
Latest News Clinical Trials Research Drugs Reports Corporate
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Pulmonary
Latest News Clinical Trials Research Drugs Reports Corporate
Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...

Respiratory
Latest News Clinical Trials Research Drugs Reports Corporate
Asthma COPD Cystic Fibrosis Pneumonia Pulmonary Medicine Respiratory Respiratory tract infections (RTIs) are any infection of the sinuses, throat, airways or lungs.  They're usually caused by viruses, but they can also ...

Advertisement