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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr.Ong Loke Meng, Penang Hospital, Malaysia
ClinicalTrials.gov Identifier:
NCT01480882
First received: November 20, 2011
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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).


Condition Intervention Phase
Chronic Bronchiectasis
Chronic Obstructive Pulmonary Disease (COPD)
Procedure: Conventional Chest Physiotherapy (CCPT)
Device: Mechanical percussion (LEGA)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Penang Hospital, Malaysia:

Primary Outcome Measures:
  • Comparing the 'wet weight' and 'dry weight' of the sputum expectorated during 20 minutes of the two procedures. [ Time Frame: 6 days ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: December 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480882

Locations
Malaysia
Penang hospital
George Town, Penang, Malaysia, 10990
Sponsors and Collaborators
Penang Hospital, Malaysia
Investigators
Study Chair: Ong L Meng, MBBS, FRCP Penang Hospital, Malaysia
Principal Investigator: Mohd I Izmi, MBBS, MD Penang Hospital, Malaysia
  More Information

Additional Information:
No publications provided

Responsible Party: Dr.Ong Loke Meng, Head, Clinical Research Centre, Penang Hospital, Malaysia
ClinicalTrials.gov Identifier: NCT01480882     History of Changes
Other Study ID Numbers: CT-11-HPP-001, NMRR-11-661-10072
Study First Received: November 20, 2011
Last Updated: December 4, 2012
Health Authority: Malaysia: Ministry of Health

Keywords provided by Penang Hospital, Malaysia:
Manual percussion
Mechanical percussion
Chronic bronchiectasis
Chronic Obstructive Pulmonary Disease
Wet sputum weight
Dry sputum weight

Additional relevant MeSH terms:
Bronchiectasis
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014