Efficacy and Safety Study of a Percussion Device to Mobilise Sputum From Respiratory Passage

Study Overview
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Brief Summary
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A Malaysian company by name Formedic Technologies SDN BHD has devised a hand held machine which is supposed to mimic the chest percussion performed by professional physiotherapist to mobilize sputum through the respiratory passage. The aim of this study is to compare the effectiveness and safety of this mechanical percussion device in the treatment of airway clearance with conventional chest physiotherapy carried out by qualified physiotherapists in patients suffering from bronchiectasis or Chronic obstructive Pulmonary disease (COPD).

Detailed Description
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This study will compare the amount of sputum expectorated during the two procedures and not intended to look at the clinical improvement of the patient.

Official Title
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A Prospective, Cross-over Randomized Trial to Assess the Efficacy and Safety of Mechanical Percussor LEGA Compared With Conventional Chest Physiotherapy in Adults With Chronic Bronchiectasis or Chronic Obstructive Pulmonary Disease (COPD

Conditions
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Chronic Bronchiectasis, Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Procedure: Conventional Chest Physiotherapy (CCPT)
* Device: Mechanical percussion (LEGA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients > 18 years of age Chronic sputum expectoration-(producing >30ml/day of sputum at baseline) Clinical diagnosis of bronchiectasis or COPD Not carrying out regular chest physiotherapy (for the purposes of this study this will be defined as less than two occasions per week) Clinically stable disease (defined as no requirement for antibiotics in the 4 weeks preceding study entry). FEV1 of > 35% of the predicted value in COPD patients Exclusion Criteria: Primary diagnosis of asthma; Active sarcoidosis Active Pulmonary tuberculosis. History of brittle bones, History of broken ribs in the past one year. History of severe osteoporosis Bleeding from the lungs or haemoptysis Experiencing intense pain in the thoracic region Clinical suspicion of increased intracranial pressure. Have head or neck injuries Have collapsed lungs or a damaged chest wall; Recent myocardial infarction, unstable angina and stroke (Within 6 months prior to enrollment) Have a pulmonary embolism or lung abscess; Have an active hemorrhage Have injuries to the spine Have open wounds or burns in the thoracic region Have had recent surgery (Within six months prior to enrollment.) Any systemic steroids within 4/52 prior to enrollment Any antibiotics within 4/52 prior to enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Chest PhysioTherapy<br>Conventional Chest Physiotherapy (CCPT) is delivered by professional physiotherapist for 15 minutes. | Procedure: Conventional Chest Physiotherapy (CCPT)<br>* Conventional chest percussion will be applied for a duration of 15 minutes.<br>* Other names: Manual percussion;|
| Experimental: Mechanical percussion<br>Mechanical percussion will be delivered by a device called LEGA for 15 minutes | Device: Mechanical percussion (LEGA)<br>* Mechanical chest percussion will be delivered by a device for 15 minutes.<br>* Other names: LEGA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing the 'wet weight' and 'dry weight' of the sputum expectorated during 20 minutes of the two procedures. | The patients will be instructed to cough out the sputum into a preweighed container during the 15 minutes of the procedure(Manual or mechanical percussion)and 5 minutes after the procedure.Container will be weighed to get the wet weight of the sputum then will be dried in a laboratory oven at 60degree c for 48 hours and weighed again to get the dry weight of the sputum | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FEV1 and FVC before and after the two methods of therapy | Any changes in the lung function will be measured as - FEV1 (%predicted) and FVC (%predicted) | 15 minutes after completion of the procedure compared to baseline | 
| Changes in pulse, blood pressure and respiratory rate | Monitoring of Pulse, blood pressure, respiratory rate, skin colour and patients reaction to treatment. | 15 minutes after completion of treatment compared to baseline | 
| Patient preference | Patients will be participating in the study for 6 days. On the 6th day after completion of treatment they will be required to answer a simple questionnaire to find out if they prefer one procedure over the other and why. | After completing 6 days of participation in the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wet sputum weight, Manual percussion, Mechanical percussion, Chronic bronchiectasis, Chronic Obstructive Pulmonary Disease, Dry sputum weight