跳至主要内容
临床试验/CTRI/2017/06/008730
CTRI/2017/06/008730已完成不适用

Comparison of Lung flute and Threshold PEP for airway clearance in Chronic Obstructive Pulmonary Disease patients: A Randomized Clinical Trial

Ms Fernandes Orein Lawrence1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Quantity of sputum

研究概览

简要总结

Chronic Obstructive Pulmonary Disease (COPD) is characterizedby mucus hypersecretion and impaired mucociliary clearance, and significantly contributesto the morbidity and mortality of this disease.According to WorldHealth Organization, 5% of all deaths globally occurred due to COPD in 2005 andit is estimated to be the third leading cause of death by 2030. In this condition,patients complain of chronic symptoms of cough, sputum production, shortness ofbreath, and/or wheezing.

Currently available mucolytics andexpectorants are not proven to be effective in COPD.The availableevidence indicates that Active Breathing Techniques such as Active Cycle of BreathingTechniques (ACBT), Autogenic Drainage and Forced Expiration, can be effective intreatment of COPD. The Passive Techniques such as Postural Drainage, Percussionas well as Supporting Techniques such as Intrapulmonary Percussive Ventilation,PEP and Non-Invasive Ventilation have little evidence due to the small numberof studies.

The Lung Flute is a new, Food andDrug Administration (FDA) approved Oscillatory Positive Expiratory Pressure(OPEP) device which has been shown to be effective in inducing sputum when usedonce. It produces a low frequency acoustic wave with an exhalation vigorous enoughto make the reed oscillate thereby increasing mucociliary clearance. ThresholdPEP has a flow independent one way valve, ensuring consistent resistancethrough adjustable specific pressure settings (in cm H2O) set by healthcareprofessionals. When patients exhale through it, the resistive load createspositive pressure that helps open the airways and allows mucus to be expelledduring “huff†coughing (Forced Expiratory Technique) thus helping in airwayclearance, bronchial hygiene and can be used as an alternate to Chest PhysicalTherapy.

             Current choices for treatment ofmucus hypersecretion are few with limited data to support their effectivenessin COPD. Although Lung Flute and Threshold PEP have found to be effective inairway clearance in COPD patients, no previous studies have been done comparingthe two devices to know which is more effective for airway clearance in thisdisease. Hence there is a need of this study to compare the two devices.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
40.00 Year(s) 至 95.00 Year(s)(—)
性别
Female

入选标准

  • •Presence of airflow obstruction by spirometry (GOLD stage 2-4).

排除标准

  • •Active tuberculosis patients; Patients with emphysematous bullae; History of cough syncope; Patients undergone abdominal, thoracic or cardiac surgeries in the last 6 months; Pregnant women; Un-cooperative patients.

结局指标

主要结局

Quantity of sputum

时间窗: Total quantity of sputum in 6 days

次要结局

  • Pulmonary Functions- Parameters (FVC, FEV1, FEV1/FVC ratio, PEFR)(Difference in Pulmonary Functions after 6 days)

研究者

发起方
Ms Fernandes Orein Lawrence
申办方类型
Other [[Self Sponsered]]

研究点 (1)

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