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Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhang Xiangyu, Tongji University
ClinicalTrials.gov Identifier:
NCT00881335
First received: April 14, 2009
Last updated: June 25, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices in elders of gerocomium.


Condition Intervention
Pulmonary Disease
 Device: flutter mucus clearance device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function

Further study details as provided by Tongji University:

Primary Outcome Measures:
  • Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher) [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]
  • MPEF,Mean Peak Expiratory Flow [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]
    indicators of pulmonary function, for example, PEF(unit of measurement:Liter per minute) All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.

  • FEV1, Forced Expiratory Volume at First Second [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]

    indicators of pulmonary function, for example, FEV1(unit of measurement:Liter)

    All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.


  • FVC, Forced Vital Capacity [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]

    indicators of pulmonary function, for example, FVC(unit of measurement:Liter)

    All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.


  • FEV1/FVC%, the Ratio of FEV1 to FVC [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]

    indicators of pulmonary function,

    All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.



Secondary Outcome Measures:
  • Number of Cases With Antibiotics Therapy [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]
    antibiotics therapy is the indicators of pulmonary infection

  • Number of Cases With Hospital Visit [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: April 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control group
Experimental: intervention
Intervention group were given flutter valve mucus clearance devices to do pulmonary function exercise
 Device: flutter mucus clearance device
five minutes every sessions, three sessions per day

Detailed Description:

Respiratory diseases are still increasing in the elderly population. The fluttering mucus clearance technique is expected to be a physical assisting therapy enhancing airway secretion clearance but needs more clinical randomized, controlled trial evidence.

  Eligibility

Ages Eligible for Study:   85 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • available to perform the device, the elders in geracomium
  • male and female
  • aging 85 years or more

Exclusion Criteria:

  • not available to perform the procedure
  • untreated pneumothorax
  • diffusion interstitial lung disease
  • acute coronary syndrome
  • third stage hypertension
  • advanced cancer
  • severe heart, liver, renal, blood system and endocrine system dysfunction
  • noninvasive mechanical ventilation
  • active hemoptysis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00881335

Sponsors and Collaborators
Tongji University
Investigators
Principal Investigator: Zhang Xiangyu, MD Shanghai Tebth People's Hospital
  More Information

No publications provided by Tongji University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Zhang Xiangyu, MD, director, professor, FCCM, FCCP., Tongji University
ClinicalTrials.gov Identifier: NCT00881335     History of Changes
Other Study ID Numbers: SHDC12007211-O
Study First Received: April 14, 2009
Results First Received: June 17, 2009
Last Updated: June 25, 2012
Health Authority: China: Ethics Committee

Keywords provided by Tongji University:
geriatric
pulmonary disease
flutter
sputum
physical therapy techniques

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013