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

Phase 2

Completed

• Conditions: Chronic Bronchiectasis; Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Procedure: Conventional Chest Physiotherapy (CCPT); Device: Mechanical percussion (LEGA)

• Registration Number: NCT01480882
• Lead Sponsor: Penang Hospital, Malaysia

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-11-20
• Study First Submitted QC: 2011-11-24
• Study First Posted: 2011-11-29
• Study Start: 2011-12
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-04
• Last Update Posted: 2012-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Adult patients > 18 years of age
2. Chronic sputum expectoration-(producing >30ml/day of sputum at baseline)
3. Clinical diagnosis of bronchiectasis or COPD
4. Not carrying out regular chest physiotherapy (for the purposes of this study this will be defined as less than two occasions per week)
5. Clinically stable disease (defined as no requirement for antibiotics in the 4 weeks preceding study entry).
6. FEV1 of > 35% of the predicted value in COPD patients

Exclusion Criteria

1. Primary diagnosis of asthma;
2. Active sarcoidosis
3. Active Pulmonary tuberculosis.
4. History of brittle bones,
5. History of broken ribs in the past one year.
6. History of severe osteoporosis
7. Bleeding from the lungs or haemoptysis
8. Experiencing intense pain in the thoracic region
9. Clinical suspicion of increased intracranial pressure.
10. Have head or neck injuries
11. Have collapsed lungs or a damaged chest wall;
12. Recent myocardial infarction, unstable angina and stroke (Within 6 months prior to enrollment)
13. Have a pulmonary embolism or lung abscess;
14. Have an active hemorrhage
15. Have injuries to the spine
16. Have open wounds or burns in the thoracic region
17. Have had recent surgery (Within six months prior to enrollment.)
18. Any systemic steroids within 4/52 prior to enrollment
19. Any antibiotics within 4/52 prior to enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Conventional Chest PhysioTherapy	Conventional Chest Physiotherapy (CCPT)	Conventional Chest Physiotherapy (CCPT) is delivered by professional physiotherapist for 15 minutes.
Mechanical percussion	Mechanical percussion (LEGA)	Mechanical percussion will be delivered by a device called "LEGA" for 15 minutes

Primary Outcome Measures

Name	Time	Method
Comparing the 'wet weight' and 'dry weight' of the sputum expectorated during 20 minutes of the two procedures.	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

Secondary Outcome Measures

Name	Time	Method
Change in FEV1 and FVC before and after the two methods of therapy	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	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	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.

Trial Locations

Locations (1)

Penang hospital; 🇲🇾 George Town, Penang, Malaysia