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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

April 14, 2009
June 25, 2012
April 2009
May 2009   (final data collection date for primary outcome measure)
  • 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.
Days of fever (body temperature reach 38 degree celsius or higher), improvement of pulmonary function [ Time Frame: one month ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00881335 on ClinicalTrials.gov Archive Site
  • 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 ]
Days of antibiotics therapy, times of hospital visit [ Time Frame: one month ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function
Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function

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

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Pulmonary Disease
Device: flutter mucus clearance device
five minutes every sessions, three sessions per day
  • No Intervention: control group
  • Experimental: intervention
    Intervention group were given flutter valve mucus clearance devices to do pulmonary function exercise
    Intervention: Device: flutter mucus clearance device
Wang QX, Zhang XY, Li Q. Effects of a flutter mucus-clearance device on pulmonary function test results in healthy people 85 years and older in China. Respir Care. 2010 Nov;55(11):1449-52.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
85 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00881335
SHDC12007211-O
Yes
Zhang Xiangyu, Tongji University
Tongji University
Not Provided
Principal Investigator: Zhang Xiangyu, MD Shanghai Tebth People's Hospital
Tongji University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP