Efficacy and Safety Study of a Percussion Device to Mobilise Sputum From Respiratory Passage (LEGA)
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).
|Chronic Bronchiectasis Chronic Obstructive Pulmonary Disease (COPD)||Procedure: Conventional Chest Physiotherapy (CCPT) Device: Mechanical percussion (LEGA)||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||"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|
- Comparing the 'wet weight' and 'dry weight' of the sputum expectorated during 20 minutes of the two procedures. [ Time Frame: 6 days ]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
- Change in FEV1 and FVC before and after the two methods of therapy [ Time Frame: 15 minutes after completion of the procedure compared to baseline ]Any changes in the lung function will be measured as - FEV1 (%predicted) and FVC (%predicted)
- Changes in pulse, blood pressure and respiratory rate [ Time Frame: 15 minutes after completion of treatment compared to baseline ]Monitoring of Pulse, blood pressure, respiratory rate, skin colour and patients reaction to treatment.
- Patient preference [ Time Frame: After completing 6 days of participation in the study ]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.
|Study Start Date:||December 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Conventional Chest PhysioTherapy
Conventional Chest Physiotherapy (CCPT) is delivered by professional physiotherapist for 15 minutes.
Procedure: Conventional Chest Physiotherapy (CCPT)
Conventional chest percussion will be applied for a duration of 15 minutes.
Other Name: Manual percussion
Experimental: Mechanical percussion
Mechanical percussion will be delivered by a device called "LEGA" for 15 minutes
Device: Mechanical percussion (LEGA)
Mechanical chest percussion will be delivered by a device for 15 minutes.
Other Name: LEGA
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480882
|George Town, Penang, Malaysia, 10990|
|Study Chair:||Ong L Meng, MBBS, FRCP||Penang Hospital, Malaysia|
|Principal Investigator:||Mohd I Izmi, MBBS, MD||Penang Hospital, Malaysia|